MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM MESH, SURGICAL

Catalog Number 1620002

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hernia (2240)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

A investigation into lot sp100409 resulted in no remarkable findings with one unrelated processing deviations and one unrelated nonconformance's revealed. As of 7/21/21, of the (b)(4) devices released to finished goods for lot sp100409, (b)(4) have been distributed. Of the (b)(4) distributed, (b)(4) have been reported as implanted. One other complaint reported against the lot. Lot sp100409 was terminally sterilized and met all qc release criteria.

Event Description

It was reported that (b)(6) year old male patient underwent hernia repair surgery on (b)(6) 2016 at (b)(6) hospital, (b)(6) and was implanted with strattice lot sp100409-083. The patient returned to the hospital on (b)(6) 2018 and had debridement of the necrotic abdominal wall including previously placed biological mesh, skin, subcutaneous tissue and muscle. On (b)(6) 2018, the patient underwent a laparotomy wound washout revision closure of the ventral hernia.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12212105
• MDR Text Key: 262985361
• Report Number: 1000306051-2021-03042
• 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

• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 1620002
• Device Lot Number: SP100409
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/01/2021
• 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 Treatment Data

Date Received: 07/22/2021 Patient Sequence Number: 1