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

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.

• Brand Name: ALLODERM SELECT SKIN GRAFT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL CORPORATION
• MDR Report Key: 9631778
• MDR Text Key: 176584680
• Report Number: MW5092486
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 1520128
• Device Catalogue Number: 1520128
• Device Lot Number: RH208059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR