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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL CORPORATION ALLODERM SELECT SKIN GRAFT MESH, SURGICAL

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LIFECELL CORPORATION ALLODERM SELECT SKIN GRAFT MESH, SURGICAL Back to Search Results
Model Number 1520128
Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2020
Event Type  Malfunction  
Event Description

Implant stated to be 8 x 16cm. Implant was significantly smaller than stated size. Implant not able to be utilized for procedure due to improper.

 
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Brand NameALLODERM SELECT SKIN GRAFT
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL CORPORATION
MDR Report Key9631778
MDR Text Key176584680
Report NumberMW5092486
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2021
Device MODEL Number1520128
Device Catalogue Number1520128
Device LOT NumberRH208059
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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