MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE SURGICAL MESH

Model Number UNKNOWN

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Based on the reported information and without an associated lot number, a relationship between the event and the strattice cannot be conclusively determined. Lifecell reports this event in an abundance of caution. Should additional clinical and product specific information be retrieved, an updated mdr will be submitted. Device not returned for evaluation.

Event Description

Limited information was reported to lifecell that a patient originally had a synthetic mesh (non-lifecell product) removed and replaced with strattice. The patient became infected and the doctor treated the area with antibiotics. The patient was also scheduled to be returned to the operating room for removal of the strattice because the area is infected again (specific dates, products, and clinical details were not provided).

• 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: 6618114
• MDR Text Key: 76852191
• Report Number: 1000306051-2017-00029
• 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

• Type of Report: Initial
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/09/2017
• 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: 06/07/2017 Patient Sequence Number: 1