MAUDE Adverse Event Report: LIFECELL MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2) MESH, SURGICAL

Catalog Number CON2006

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

Patient Problems Cellulitis (1768); Seroma (2069)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

Device was not returned for analysis, as reporter indicated the device was sent for cultures. Internal investigation into lot sp200194 resulted in no remarkable findings including (b)(4) devices released to finished goods, 285 have been distributed, 11 have been reported as implanted. There has been 1 other similar complaint (mfr # 1000306051-2020-00032), and 2 unrelated complaints reported to allergan against this lot. The lot was aseptically processed, terminally sterilized, and met qc release criteria. There were no processing deviations and 1 unrelated nonconformance related to the nature of this complaint. Based on the reported information, a relationship between the event and strattice cannot be determined. If additional information is reported, a follow up adverse event report will be submitted. No further actions are required as a nonconformance could not be confirmed.

Event Description

Healthcare professional reported patient was implanted with strattice for breast augmentation on (b)(6) 2020. Patient had bilateral jp drains removed on (b)(6) 2020 - drains had 24-hour output of 15-20 cc each. Patient returned to the office on (b)(6) 2020 for follow up with complaints of progressive swelling in bilateral breasts. ¿dr. (b)(6)¿s exam showed tense, nontender breast with mild erythema. " "patient developed heavy seroma output around the strattice". The decision was made at that time to return to the operating room (or) to remove washout both breasts & remove strattice. " ¿fluid was evacuated in surgery on (b)(6) 2020, sent for cultures, which were negative". Strattice was unincorporated at the time of explant. The explanted strattice were also sent for cultures, the results were not reported. Patient sent to infectious disease & received iv antibiotics. Ceftriaxone 2 g iv q 24 hours & daptomycin 320 mg iv q 24 hours on (b)(6) 2020 for 2 weeks. It was reported that the seroma lead to the patient having cellulitis. Patient is "currently off of antibiotics and doing well".

• Brand Name: MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
• 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 ; 9089471470
• MDR Report Key: 10391133
• MDR Text Key: 208968430
• Report Number: 1000306051-2020-00034
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K082176
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2021
• Device Catalogue Number: CON2006
• Device Lot Number: SP200194
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• 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: 08/11/2020 Patient Sequence Number: 1