MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number 2025002

Device Problem Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Method of evaluation: actual device not evaluated; manufacturing review.Review of information as reported, review of the device history records and complaint history records associated with lot sp100401.Results of evaluation: no failure detected.Review of lot processing history and complaint history records for lot sp100401 was unremarkable.There were no processing deviations or nonconformance related to the nature of this complaint and the lot met qc criteria for release, including mechanical testing results.As of 03/24/2017, one other complaint ((b)(4)) was reported to lifecell against lot sp100401.As per the surgeon, the strattice did not cause or contribute to the event.The event is unrelated to strattice and not reportable to the fda.As of 03/24/2017, of the (b)(4) devices released to finished goods for lot sp100401, (b)(4) devices were distributed.Evaluation conclusion: device not returned; device failure related to patient condition.The event is unlikely related to strattice and likely due to the patient's post operative occupational activities which involves lifting heavy loads.Based on our internal review of the device processing history, the lot met qc criteria for product release.No deviations were encountered in association with the event.No other similar complaints were reported to lifecell against the lot.Device not returned for evaluation.

Event Description

It was reported that a (b)(6) male patient underwent ventral hernia repair with component separation and stress mesh repair on (b)(6) 2016.Status post operatively, the strattice split down the middle.It was explained that the patient started rehab for his job which involves carrying heavy loads.The strattice "held up until the patient began holding more and more." the patient is scheduled to repeat abdominal wall reconstruction on (b)(6) 2017.

• Brand Name: STRATTICE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): LIFECELL CORPORATION; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; one millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 6440322
• MDR Text Key: 71093458
• Report Number: 1000306051-2017-00013
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: 2025002
• Device Catalogue Number: N/A
• Device Lot Number: SP100401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR