MAUDE Adverse Event Report: LIFECELL 6CM X 10CM STRATTICE FIRM STOMA REINFORCED SHEET; MESH, SURGICAL

Catalog Number 0610008

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240)

Event Date 12/31/2015

Event Type  Injury  

Manufacturer Narrative

Internal investigation into strattice lot s10625 included a review of the reported information, review of the device history records, and a review of the complaint history records with no remarkable findings, including no other complaints reported against the lot and no deviations or non-conformances revealed during processing.The lot was aseptically processed, terminally sterilized within the process parameters and met all qc release criteria.As of 16/oct/2018, of the (b)(4) devices released to finished goods, (b)(4) have been distributed with (b)(4) devices reported as implanted.Multiple attempts are being made to obtain relevant medical records of the patient's explant surgery.Due to the limited information reported, including lack of clinical details, a relationship between the strattice and this event could not be determined.No further actions are required as a nonconformance could not be confirmed.If additional information is received, a supplemental report will be submitted.

Event Description

Limited information was reported by a patient through voluntary mw5079728 that following a surgery where strattice was implanted on (b)(6) 2010, the patient had pain that kept getting worse.The patient underwent a ct scan where she was advised that the hernia mesh was "pulling her bladder".The patient subsequently underwent emergency surgery on (b)(6) 2015 with device explant.It was confirmed that this was not reported to lifecell as a complaint at the time of event by neither the patient nor their health care professional.Additional information received from the patient's records indicates this procedure was for a recurrent right side inguinal hernia.

Manufacturer Narrative

Based on the updated information, the conclusion remains unchanged.A relationship to the strattice cannot be determined and a nonconformance was not confirmed.No additional information about the condition of the strattice mesh or its removal was reported in the operative notes.As reported in the initial: internal investigation into strattice lot s10625 included a review of the reported information, review of the device history records, and a review of the complaint history records with no remarkable findings, including no other complaints reported against the lot and no deviations or non-conformances revealed during processing.The lot was aseptically processed, terminally sterilized within the process parameters and met all qc release criteria.(b)(4).Multiple attempts are being made to obtain relevant medical records of the patient's explant surgery.Due to the limited information reported, including lack of clinical details, a relationship between the strattice and this event could not be determined.No further actions are required as a nonconformance could not be confirmed.If additional information is received, a supplemental report will be submitted.

Event Description

This is a follow up #1 to report that on 19/nov/2018, a cd of the patient's medical records was received and reviewed: this patient underwent right groin re-exploration, removal of non-allergan patch and plug and repair of right groin with strattice mesh on (b)(6) 2010.Operative notes report that the strattice was placed for repair of the remaining inguinal floor defect.The mesh was secured inferomedially to the pubic tubercle.Oblique fascia was closed over strattice mesh following re-approximation of the scarpa fascia.The patient was readmitted to the hospital on (b)(6) 2015 due to abdominal pain on-going for about a month.The patient had a ct scan of the abdomen and pelvis demonstrating herniation of her bladder into the hernia sac and was returned to surgery the same day for exploratory laparotomy, lysis of adhesions, repair of incarcerated, recurrent right inguinal hernia and placement of a non-allergan mesh.Description of findings reported the bladder protruding into hernia, adhesions and that the ¿old mesh was identified¿.The patient was discharged on (b)(6) 2016.No additional information about the condition of the strattice mesh or its removal was reported in the operative notes.As reported in the initial: limited information was reported by a patient through voluntary (b)(4) that following a surgery where strattice was implanted on (b)(6) 2010, the patient had pain that kept getting worse.The patient underwent a ct scan where she was advised that the hernia mesh was "pulling her bladder".The patient subsequently underwent emergency surgery on (b)(6) 2015 with device explant.It was confirmed that this was not reported to lifecell as a complaint at the time of event by neither the patient nor their health care professional.Additional information received from the patient's records indicates this procedure was for a recurrent right side inguinal hernia.

• Brand Name: 6CM X 10CM STRATTICE FIRM STOMA REINFORCED SHEET
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 8014056
• MDR Text Key: 125298410
• Report Number: 1000306051-2018-00133
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Catalogue Number: 0610008
• Device Lot Number: S10625
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATENOLOL, EFFLEXOR, ATORVASTATIN; ATENOLOL, EFFLEXOR, ATORVASTATIN
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR