MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number 2030002

Device Problem Material Disintegration (1177)

Patient Problem Wound Dehiscence (1154)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: date is estimated.(b)(4).Qa investigation into lot sp100286 resulted in no remarkable findings including (b)(4) devices distributed with no other complaints reported against the lot and no related deviations or nonconformances revealed during processing.Lot sp100286 was terminally sterilized and met all qc release criteria.Due to the limited information reported, a relationship between the device and the event could not be conclusively determined.Lifecell has made multiple attempts to obtain additional patient and procedure specific information, but to date no information has been received.If additional information is received, a follow up report will be filed.Device not returned.

Event Description

It was reported to lifecell that a (b)(6) female patient underwent an open abdomen procedure with strattice implanted on (b)(6) 2016.On 7/11/2016, the surgeon reported to the lifecell sales representative that the patient has an open belly and the strattice had broken down in a few areas, leaving the bowel exposed.It was reported that the surgeon was returning the patient to the or and requested to consult with a lifecell medical representative to discuss the use of vicryl with strattice.The surgeon expressed that they wanted to know how strattice would handle vicryl being put over the strattice and a new piece of strattice over the vicryl.A lifecell medical representative attempted to contact the surgeon, but was unsuccessful.Lifecell has made multiple attempts for additional patient and procedure specific information, but to date no other information has been received regarding this event.

• Brand Name: STRATTICE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): LIFECELL CORPORATION; one millennium way; branchburg NJ 08876
• Manufacturer Contact: stanley dube ; one millennium way; branchburg, NJ 08876 ; 9089471575
• MDR Report Key: 5855052
• MDR Text Key: 51701866
• Report Number: 1000306051-2016-00046
• 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: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2017
• Device Model Number: 2030002
• Device Catalogue Number: N/A
• Device Lot Number: SP100286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/12/2015
• 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: 42 YR