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Adrett Kranken – Schutzdecke Bettschurze

Notice type: Warning

Date: 21/03/2003

  

Product name or type:
Adrett Kranken – Schutzdecke Bettschurze

Reference:
SN2003(04)

Manufacturer Or Supplier:
L.u.M Povel GmbH

Target Audience:
Health Boards; Hospital Managers; Managers of Learning Disability Services; Managers, Residential Care Units; Medical, Nursing and Care Staff ;Community Health Care Staff; Supplies Officers; Risk Managers

Problem Or Issue:
Fatal strangulation of two patients in Germany when using the protection – blanket in bed.

Background Information Or Related Documents:
The Adrett Kranken – Schutzdecke / Bettschurze is a blanket that is used with patients post operatively to prevent then from touching recently operated or contaminated parts of the body   

The blanket is fixed to the patient''s bed with several ties. Two patients in Germany, when attempting to leave the bed, became entrapped in the blanket, which resulted in strangulation.  The manufacturer is now recalling the device from use.    

We are also aware that this blanket has been used for patients suffering from incontinence.   

The Irish Medicines Board has contacted the manufacturer but has not been able to obtain confirmation that the product is not on the Irish market. The device was sold in Germany and Austria, but marketing in other countries cannot be excluded.

Adrett Kranken – Schutzdecke Bettschurze Document

Actions To Be Taken:
  • Determine if you have such devices in use in your centre.  
  • Examine the information for use provided with the device to determine if either the name or manufacturer detail match those provided above:
    • The device may be marketed in Ireland under an English name.
    • The manufacturers name should be the same.
  • Ensure that product is removed from use, labelled and quarantined.
  • Contact the distributor from which you purchased the blanket and arrange for collection.
  • Ensure that all relevant staff is advised of the potential serious risk of strangulation with such restraining products.

Further Information:
All adverse incidents relating to a Medical Device should be reported to the:   

Medical Devices Department 
Health Products Regulatory Authority
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

If you have any enquiries, you may contact the Medical Devices Department at:   

Telephone:      +353-1-6764971 
Fax:                +353-1-6767836 
Email:              vigilance@imb.ie 
Website:          www.hpra.ie 

Enquiries to the manufacturer should be addressed to the address below and copied to the HPRA:   
L.u.M Povel GmbH 
Waldstrasse 24 c 
45661 Recklinghausen 
Germany

Telephone:      +49-2361-3778-0

SN2003(04): Adrett Kranken – Schutzdecke Bettschurze

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