MAUDE Adverse Event Report: UNKNOWN STRATTICE MESH, SURGICAL

Catalog Number UNK STRATTICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Necrosis (1971)

Event Date 01/15/2015

Event Type  Injury  

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported complications with surgical intervention. The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed. No strattice devices were returned for evaluation. Based on the limited information reported, a relationship between the event and strattice cannot be confirmed. Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

Event Description

It was reported through a legal event that a (b)(6) year old female patient had ventral incisional hernia repair surgery on or about (b)(6) 2014. During the hernia repair surgery, the surgeon implanted a strattice mesh. After surgery, the patient returned to the hospital on or about (b)(6) 2015 and was diagnosed with ischemic necrosis of the central portion of her midline incision. On or about (b)(6) 2015, the patient underwent the excision and debridement of an open abdominal wound. On or about (b)(6) 2015, the patient underwent abdominal wall debridement with wound vac placement. The strattice mesh was noted to have separated from the healing tissue and was incised. The patient presented several more times throughout 2015 for treatment of abdominal wall pain, wound infection, and dehiscence, and underwent additional excisional debridement of abdominal wound.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 13845499
• MDR Text Key: 287596039
• Report Number: 1000306051-2022-00042
• 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,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2022
• 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: 03/22/2022 Patient Sequence Number: 1

Treatment

NO INFORMATION REPORTED