MAUDE Adverse Event Report: 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 Code	Cellulitis (1768)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal investigation into strattice lot sp200337 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.
Event or Problem Description
Limited information was reported on (b)(6) 2022 from the sales rep on behalf of the hcp that they had a patient who had surgery on (b)(6) 2022 with strattice and she ended up having an implant exchange and had her strattice removed on (b)(6) 2022 d/t cellulitis.The lots associated with this event were reported as right breast: (b)(4) and left breast: (b)(4).This record is associated with left breast: (b)(4).Refer to mdr 1000306051-2022-00167 for the right breast investigation.
Event or Problem Description
This is follow up#1 to report additional information was received from the medical staff on (b)(6) that the patient was a 68 year old female with a history of dcis in 2003, had a mastectomy and reconstruction at that time.She had implant exchange in 2005.Her comorbidities included warm autoimmune hemolytic anemia, hyperlipidemia, diverticulitis.On (b)(6) 2022 , she underwent a conversion from subpectoral to prepectoral and implants placed on (b)(6) 2022 were right: 600 cc, left: 650 cc.This was a bilateral breast reconstruction revision.The symptoms presented unilaterally, on the left with an onset date of (b)(6) 2022.The patient had to have left implant removed on (b)(6) 2022, and will be re-reconstructed in spring 2023.Some of the adm was noticed to be integrated so adm was partially explanted.The health care provider does attribute the strattice device to the cellulitis.Additional information and clarification were received on (b)(6) that event is only related to the left side and the strattice remains implanted on the right side.There is no allegation or adverse event reported for the right side.As reported in the initial: limited information was reported on 15/sep/2022 from the sales rep on behalf of the hcp that they had a patient who had surgery on (b)(6) 2022 with strattice and she ended up having an implant exchange and had her strattice removed on (b)(6) 2022 d/t cellulitis.The lots associated with this event were reported as right breast: sp200334065 and left breast: sp200337357.This record is associated with left breast: sp200337357.Refer to mdr 1000306051-2022-00167 for the right breast investigation.
Additional Manufacturer Narrative
Although the hcp attributes the cellulitis to the device, based on the results of the investigation, including the device was partly integrated on the left side, remains implanted on the right side, a relationship to the strattice cannot be conclusively determined.The lot was terminally sterilized within the process parameters and met all qc release criteria.As reported in the initial: internal investigation into strattice lot sp200337 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.

• Brand Name: MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 15538678
• Report Number: 1000306051-2022-00165
• Device Sequence Number: 6107535
• Product Code: FTM
• UDI-Device Identifier: 00818410010270
• UDI-Public: 00818410010270
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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 Expiration Date: 08/31/2023
• Device Catalogue Number: CON2006
• Device Lot Number: SP200334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BREAST IMPLANTS (B)(6) 2022.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female