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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL CORP. ALLODERM MESH, SURGICAL

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LIFECELL CORP. ALLODERM MESH, SURGICAL Back to Search Results
Model Number 1520128
Device Problem Device Contamination With Biological Material (2908)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2017
Event Type  malfunction  
Event Description
During breast reconstructive surgery alloderm select 8 cm x 16 cm was noted to have a hair in the product, so it was not used.
 
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Brand NameALLODERM
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL CORP.
one millennium way
branchburg NJ 08876
MDR Report Key6431765
MDR Text Key70793450
Report Number6431765
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/28/2017,03/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model Number1520128
Device Lot NumberRH118942-0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/28/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer02/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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