MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM; MESH, SURGICAL

Catalog Number 3030002

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Review of the processing history records for lot sp200237 is as follows: pouch integrity inspection showed no significant bulges, holes, tears, wrinkles or physical defects.The lot was aseptically processed, terminally sterilized, and met qc release criteria.There were no processing deviations or nonconformances related to the nature of this complaint.As of 5/4/2021, of the (b)(4) devices released to finished goods for lot sp200237, 170 have been distributed.Of the (b)(4) distributed, (b)(4) have been reported as implanted.

Event Description

On 26/apr/2021 ps received an email from (b)(6) rep on behalf of dr.(b)(6) reporting, a 30x30 piece of strattice with serial (b)(4) was implanted (b)(6) on a hernia patient without closure.At 2.5 weeks and one month post op a hole developed on the side of the strattice.One side there was partial integration and the other side there was some holes which the doctor felt deterioration.Replacement surgery is not scheduled at this time.They continue to monitor the open hernia.Implanting surgeon was dr.(b)(6) in (b)(6).

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ
• Manufacturer (Section G): BRANCHBURG; one millennium way; branchburg NJ 08876
• Manufacturer Contact: chris belle ; one millennium way; branchburg, NJ ; 9089471470
• MDR Report Key: 11816066
• MDR Text Key: 250465854
• Report Number: 1000306051-2021-00039
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 3030002
• Device Lot Number: SP200237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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