MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE; MESH, SURGICAL

Catalog Number UNK STRATTICE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Conclusion: based on limited information, including no identification of the relevant lot number, a relationship between the event and strattice could not be determined.Due to lack of information, strattice as a contributing factor cannot be ruled out.Lifecell reports the event in an abundance of caution.Multiple attempts to obtain additional information are being made, including identification of the lot number.Should additional information be reported, a follow up adverse event report will be submitted; otherwise this investigation is concluded.

Event Description

This report is associated with the right-side strattice mesh.Please refer to mdr 1000306051-2018-00042 for the left-side strattice mesh report.It was reported that a (b)(6) year old female patient had previously undergone bilateral mastectomy, tissue expander, and implant reconstructions.On (b)(6) 2018, the patient was returned to surgery for partial capsulectomy, revision, and repair.Intraoperatively, the right side showed poor ingrowth of strattice and required debridement and replacement of the breast implant.The revision was completed and the patient was taken to recovery in good condition.

• Brand Name: UNKNOWN STRATTICE
• 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 ; 9089471100
• MDR Report Key: 7343099
• MDR Text Key: 102580096
• Report Number: 1000306051-2018-00041
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention