MAUDE Adverse Event Report: LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3); MESH, SURGICAL

Catalog Number	CON3006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qa investigation into lot sp200289 resulted in no remarkable findings including 236 devices distributed with no other complaints reported against the lot and no related deviations or nonconformances revealed during processing.Lot sp200289 was terminally sterilized within the process parameters and met all qc release criteria.Based on the results of the investigation, a relationship between the strattice and this event could not be determined.No further actions are required at this time, as a nonconformance could not be confirmed.
Event or Problem Description
It was reported that on (b)(6) 2021, the surgeon operated on a female patient and used two pieces of strattice con3006, one on the right side and one on the left side.Approximately 3 weeks post-op, she presented in the office with redness and swelling of the right breast.The surgeon ended up taking the patient to the operating room and found a large seroma in which he drained roughly 150-200cc¿s of fluid.That fluid was sent to pathology and cultured.The culture came back positive for gram negative bacteria coccobacilli.Strattice was removed at that time due to the positive culture and antibiotics were given post op.The surgeon saw the patient back in the office on 7/19 and she is unfortunately tightening up again on her right breast.The surgeon will need to take her back to surgery again and is booked for (b)(6) 2021.The surgeon will do a right capsulectomy at that time, put in a new implant and a new piece of strattice.Additional information was received that this was a healthy cosmetic patient with no reported comorbidities.The symptoms are only pertaining to the patient's right breast, but the doctor does not indicate a relationship between the strattice and the infection.

• Brand Name: LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3)
• Common Device Name: MESH, SURGICAL
• MDR Report Key: 12342722
• Report Number: 1000306051-2021-03046
• Device Sequence Number: 3938144
• Product Code: FTM
• UDI-Device Identifier: 00818410010294
• UDI-Public: 00818410010294
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CON3006
• Device Lot Number: SP200289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION
• Outcome Attributed to Adverse Event: Required Intervention