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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL CORPORATION ALLODERM SELECT REGENERATIVE TISSUE MATRIX MESH, SURGICAL

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LIFECELL CORPORATION ALLODERM SELECT REGENERATIVE TISSUE MATRIX MESH, SURGICAL Back to Search Results
Model Number CM1520
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 01/28/2020
Event Type  malfunction  
Event Description
Lifecell, alloderm select, regenerative tissue matrix, was opened but was not the same size as what was indicated on the packaging. Fda safety report id# (b)(4).
 
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Brand NameALLODERM SELECT REGENERATIVE TISSUE MATRIX
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL CORPORATION
branchburg NJ 08876
MDR Report Key9659202
MDR Text Key177629526
Report NumberMW5092683
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 01/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCM1520
Device Catalogue NumberCM1520
Device Lot NumberRH214423-011
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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