MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH FORTIVA PORCINE DERMIS

Lot Number PD17210001

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

Patient Problems Necrosis (1971); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

The graft remains implanted.Therefore, a comprehensive records re-review was conducted.There were no departures noted during records re-review that would negatively impact the manufacturing of xenografts from lot pd17210001.Manufacturing records indicated that all xenografts manufactured from the lot met all specifications and release criteria prior to distribution.There is one related complaint for seroma formation for the lot, also associated with the same physician (name not reported at this time).Porcine dermis xenografts undergo a validated sterilization method: tutoplast®, which includes terminal sterilization by gamma irradiation after packaging.To date, our investigation indicates that the reported complications are more likely associated with one or more extrinsic factors, rather than an intrinsic property of the fortiva porcine dermis xenografts.

Event Description

Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly owned subsidiary of rti, received a complaint as part of the fortiva appear trial.The reported complaint indicated that a patient underwent a right nipple conserving mastectomy.Two drains were placed (right axilla removed after being placed for more than 13 days).The patient was discharged with no additional medications on (b)(6) 2019.On (b)(6) 2019 the patient was noted to have developed skin necrosis and seroma.The seroma was aspirated on (b)(6) 2019 and (b)(6) 2020.Dressings were applied over the area of skin necrosis.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: PORCINE DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrabe 6; neunkirchen am brand 97077 ; GM 97077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, fl ; 4188888436
• MDR Report Key: 9714073
• MDR Text Key: 188684752
• Report Number: 3002924436-2020-00006
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/31/2021
• Device Lot Number: PD17210001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 66 YR
• Patient Sex: Female