MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH FORTIVA PORCINE DERMIS; PORCINE, DERMIS PRODUCT CODE: FTM

Lot Number PD18300001

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

Patient Problem Seroma (2069)

Event Date 11/02/2021

Event Type  Injury  

Manufacturer Narrative

Based on the limited information provided; the grafts remain implanted.According to records review, serial id#: (b)(4) processed from the lot met all acceptance / inspection criteria prior to distribution.The graft was manufactured to the specification detailed in sp (b)(4)"04", annex 1-3 "06", annex "02".This case is considered not serious by the reporting investigator and by tutogen as no medical intervention had to be performed due to the event.Seroma is frequently reported after surgery, especially, when lymphatic vessels have been cut, for example during breast reconstruction with lymph node resection due to breast cancer.Additionally, seroma may be caused by patient individual reasons (e.G.Individual poor wound healing, high activity level), by the surgical procedure itself or e.G.By an implant that influences wound healing (e.G.The implanted silicone.Implants).However, the reporter clarified that the patient did not have any relevant medical history (except for the use of tobacco and the chemotherapy) and no relevant concomitant medications have been administered that may have contributed to the formation of the seroma.A batch documentation analysis has been performed and revealed no issues during the production process.The investigator reported the causality of seroma as unknown regarding the fortiva membrane and related regarding the procedure.However, the date of the surgical procedure was reported as (b)(6) 2021 and the event onset as (b)(6) 2021.Timely relationship is therefore considered rather not plausible.Therefore, tutogen considers the event as not related.Seroma is already described in the ifu.

Event Description

It was reported that a female patient underwent implantation of a fortiva tissue matrix graft as part of the (b)(6) clinical trial and developed a small seroma at the left side.It was reported that the event was assessed as non-serious and related to the procedure and it was unknown if it was related to the device.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: PORCINE, DERMIS PRODUCT CODE: FTM
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrabe 6; neukirchen am brand, 91077 , DE; GM 91077, DEU
• Manufacturer (Section G): RTI SURGICAL INC.; 11621 research circle; alachua FL 32615
• Manufacturer Contact: charity emmons ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 13714931
• MDR Text Key: 286948489
• Report Number: 3002924436-2022-00003
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/09/2022

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
• Device Expiration Date: 11/30/2021
• Device Lot Number: PD18300001
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female