MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6CM X 8CM, PLIABLE MESH, SURGICAL

Catalog Number 0608001

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

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

Event Date 01/03/2015

Event Type  Injury  

Manufacturer Narrative

The internal investigation into strattice lot s10693 included a review of the reported information, review of the device history records and review of the complaint history records. The device was not returned to lifecell for evaluation. Investigation results revealed no remarkable findings with no similar complaints reported against the lot and no related deviations or nonconformances revealed during processing associated with the nature of the event. The lot was terminally sterilized within the process parameters and met all qc release criteria. To date, of the 483 devices released to finished goods for lot s10693, 482 have been distributed. No further actions are required as a nonconformance could not be confirmed.

Event Description

It was reported that a (b)(6) year old female underwent hernia repair surgery on (b)(6) 2010 with dr. (b)(6) who preformed the incarcaerated hernia repair in (b)(6) and placed strattice lot s10693-287. After the surgery, the patient returned to the hospital on (b)(6) 2015 and was diagnosed with an incarcerated hernia recurrence with strangulated bowel. The surgeon placed a second piece of strattice - lot sp10069-167 and performed the revision surgery. The patient returned to the hospital on (b)(6) 2019 and was diagnosed with a small bowel obstruction and the strattice mesh was balled up on the edges requiring removal of the mesh. It was not reported if both lots were explanted. This complaint investigation is associated to lot s10693-287.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6CM X 8CM, PLIABLE
• 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: 12080544
• MDR Text Key: 268135609
• Report Number: 1000306051-2021-03009
• 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: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0608001
• Device Lot Number: S10693
• 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: 06/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2010
• 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: 06/28/2021 Patient Sequence Number: 1