MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM MESH, SURGICAL

Catalog Number 2540002

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

Patient Problems Hernia (2240); Obstruction/Occlusion (2422)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent a hernia repair with strattice and was later diagnosed with an acute small bowel obstruction with incarcerated hernia requiring removal of the strattice mesh. The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.

Event Description

It was reported that a (b)(6) year old male patient underwent a hernia repair on (b)(6) 2016 at (b)(6) in (b)(6) and was implanted with strattice lot sp100442-201. After the surgery, the patient returned to the hospital on (b)(6) 2019 and was diagnosed with an acute small bowel obstruction with incarcerated hernia requiring removal of the strattice mesh at (b)(6).

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, 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: 12124588
• MDR Text Key: 268135363
• Report Number: 1000306051-2021-03013
• 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,Followup,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 2540002
• Device Lot Number: SP100443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/15/2021
• 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: 07/06/2021 Patient Sequence Number: 1