MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM; MESH, SURGICAL

Catalog Number 2020002

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hernia (2240)

Event Date 01/18/2010

Event Type  Injury  

Manufacturer Narrative

Qa investigation into lot s10546 resulted in no remarkable findings and no deviations and no nonconfromances revealed.(b)(4) devices were released to finished goods.(b)(4) reported as implanted (b)(4) have been distributed.No other complaints against.Lot s10546 were revealed.Lot s10546 was aseptically processed, terminally sterilized and met all qc release criteria.

Event Description

Patient representative reports a (b)(6) yo male patient had a hernia repair with strattice on (b)(6) 2009.On (b)(6) 2010, a removal of the mesh was required and a repair of the incisional hernia.Partial known lot s10546 catalog 2020002.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 11991263
• MDR Text Key: 255933859
• Report Number: 1000306051-2021-03005
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2020002
• Device Lot Number: S10546
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR