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

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.

• Brand Name: ALLODERM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL CORP.; one millennium way; branchburg NJ 08876
• MDR Report Key: 6431765
• MDR Text Key: 70793450
• Report Number: 6431765
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2017,03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2018
• Device Model Number: 1520128
• Device Lot Number: RH118942-0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR