MAUDE Adverse Event Report: TUTOGEN MEDICAL, GMBH FORTIVA PORCINE, DERMIS

Lot Number MP163501

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Impaired Healing (2378)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Rti (b)(4) conducted a batch documentation review for serial id (b)(4) manufactured from lot mp163501. No departures were noted during processing. Serial id (b)(4), was manufactured to the specification detailed in (b)(4) "04"; annex 1-3 "05". The graft met all acceptance / inspection criteria prior to distribution. (b)(4). The vacuum assisted closure device was removed nine months post-operatively. Delayed wound healing can have many causes, (e. G. Injuries, surgeries, failure of blood supply, infection or radiation therapy. The patient did not have any confounding factors such as a special medical history, (b)(6) use, post-operative infection or immunosuppression. In general, hypersensitivity reactions to porcine collagen are a well known phenomenon and are described in the ifu of the fortiva product. However, since the patient's symptoms of an allergic reaction developed nine months post-operatively and only in one breast, it is more plausible that the adverse event is associated with a source or event extrinsic to the fortiva graft.

Event Description

(b)(6) and tutogen medical (b)(4) (tmi), a wholly subsidiary of (b)(6), received a complaint as part of the fortiva appear study. The complaint indicated that the patient underwent a bi-lateral breast reconstruction post mastectomy on (b)(6) 2020 with implantation of an rti fortiva graft. One silicon expander was implanted in her left breast. Two lymph nodes were removed and one drain remained indwelling. Nine months post-operatively, the patient developed a rash on (b)(6) 2020. The patient underwent removal of the left expander and placement of a new 250ml implant. On (b)(6) 2020, the patient underwent removal of the vacuum assisted closure device. On (b)(6) 2021, it was reported that the patient experienced delayed wound healing which was treated with antibiotics for prophylactic measures. The event resolved on (b)(6) 2021 with no residual effects. On 06/17/2021, information was provided to rti (b)(4) that the adverse event was procedure related and not device related. Follow-up information provided to rti (b)(4) on 09/14/2021, indicated that it is unknown if the patient's allergic reaction was related to the silicon implant or the fortiva graft.

• Brand Name: FORTIVA
• Type of Device: PORCINE, DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL, GMBH; industriestrasse 6; neunkirchen am brand; deu, germany 91077 ; GM 91077
• MDR Report Key: 12601608
• MDR Text Key: 284621153
• Report Number: 3002924436-2021-00026
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2020
• Device Lot Number: MP163501
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/08/2021 Patient Sequence Number: 1