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

Catalog Number	CON2006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Seroma (2069)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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)
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 10391133
• Report Number: 1000306051-2020-00034
• Device Sequence Number: 2004741
• Product Code: FTM
• UDI-Device Identifier: 00818410010270
• UDI-Public: 00818410010270
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: CON2006
• Device Lot Number: SP200194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention