MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM; MESH, SURGICAL

Catalog Number 1010002

Device Problem No Apparent Adverse Event (3189)

Patient Problem Hernia (2240)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

Qa investigation into lot s11293 resulted in no remarkable findings and no deviations and no nonconfromances revealed.192 devices were released to finished goods and (b)(4) have been distributed.Of the 167 distributed, 100 have been reported as implanted.Lot s11293 was terminally sterilized and met all qc release criteria including mechanical testing.

Event Description

Patient underwent incisional hernia repair surgery and strattice mesh was implanted.Patient returned to hospital approximately 6 years later and was diagnosed with recurrent ventral hernia and bilateral inguinal hernia direct.Recurrent incisional ventral hernia repair, bilateral retrorectus component separation, bilateral direct inguinal hernia repair and explant of mesh completed.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ ; 9089471470
• MDR Report Key: 11586028
• MDR Text Key: 245092379
• Report Number: 1000306051-2021-00021
• 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: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 1010002
• Device Lot Number: S11293
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2013
• 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: 57 YR