MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL

Catalog Number UNK STRATTICE

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

Patient Problems Cellulitis (1768); Fistula (1862); Seroma (2069)

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. The device remains implanted. 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

It was reported that a female patient underwent a reduction mammoplasty and was excessively reduced. (date of surgery was not provided). In a follow up procedure, the patient underwent a breast implant procedure to increase volume. She also had three or four breast augmentation revisions including an initial revision in the summer of 2017 using strattice bilaterally to reinforce lateral capsulorrhaphy. The patient did well but received a steroid injection in her back sometime in (b)(6) 2017. (no indication was provided). Subsequently, the patient started thinning at her lateral breast soft tissue. In (b)(6) 2018, the patient developed cellulitis and seroma which responded to clindamycin. A breast implant migrated cephalad and then returned to normal position. In (b)(6) 2018, the patient developed recurrent seroma, cellulitis, and had spontaneous drainage of the seroma. She now has a small fistula tract.

• 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: 7441755
• MDR Text Key: 105882316
• Report Number: 1000306051-2018-00050
• 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

• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK STRATTICE
• 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: 03/22/2018
• 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 Treatment Data

Date Received: 04/18/2018 Patient Sequence Number: 1