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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ADULT BODY BAGS WITH ID TAGS GENERAL SURGERY TRAY

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MEDLINE INDUSTRIES, INC. ADULT BODY BAGS WITH ID TAGS GENERAL SURGERY TRAY Back to Search Results
Model Number NON70548WM
Device Problems Component Missing (2306); Tear, Rip or Hole in Device Packaging (2385); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2020
Event Type  Malfunction  
Event Description

Post mortem body bags are thin and weak and sometimes the sling harness is missing. When the body bags reach cold temperatures, they become brittle and rip in the process of moving patients out of the morgue and onto the funeral home stretchers. With the body bags ripping, employees may be exposed to infection (ie. Covid-19).

 
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Brand NameADULT BODY BAGS WITH ID TAGS
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key10060921
MDR Text Key191129671
Report Number10060921
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 05/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberNON70548WM
Device LOT NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/07/2020
Event Location Hospital
Date Report TO Manufacturer05/15/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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