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

Lot Number PD17380001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Rash (2033); Seroma (2069)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

It is unknown at this time if the graft remains implanted.A comprehensive records re-review will be conducted.Once results are available, a follow-up will be submitted.

Event Description

Rti surgical, inc and tutogen medical gmbh (tmi), a wholly subsidiary of rti, recevied a complaint on 08/17/2021, as part of the fortiva appear trial.The reported complaint indicated that the patient (subject id (b)(6)) underwent a breast reconstruction on (b)(6) 2021 with implantation of fortiva porcine dermis and developed a seroma on (b)(6) 2021.

Manufacturer Narrative

There were no departures noted during records that had a negative impact of the manufacturing of fortiva grafts from lot pd17380001.There were no related complaints for the lot.All fortiva® tissue matrix grafts undergo a validated sterilization methodology; tutoplast®.Manufacturing records indicate that the xenograft implant with serial id (b)(6) manufactured from the lot met all specification requirements at the time of release.

Event Description

Follow-up information received on 09/01/2021,stated that the patient reported "redbreast on the right side and exanthema on the whole body.The patient was treated with an antiallergic medication for both the seroma and exanthema.The "redbreast" was treated with antibiotic.Outcome of the event was resolved on (b)(6) 2021.It was clarified that the patient did not have any relevant medical history and no concomitant medications.All three events have been assessed as not serious and are described in the instructions for use (ifu), (exanthema only as allergic reaction).Batch documentation analysis revealed that serial id (b)(6) was manufactured according to al specifications and met all release.

• Brand Name: FORTIVA
• Type of Device: PORCINE DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL, GMBH; industriestrabe 6; neunkirchen am brand, germany 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: 12475619
• MDR Text Key: 271540225
• Report Number: 3002924436-2021-00025
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Lot Number: PD17380001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female