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

Lot Number PD18100001

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

Patient Problem Hematoma (1884)

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 pd18100001.Manufacturing records indicated that serial id (b)(4) 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 (b)(4), 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 left nipple conserving mastectomy.Two drains were placed (one in chest wall was removed (b)(6) 2019; one in the axilla was removed on (b)(6) 2019).On (b)(6) 2019 the patient was noted to have developed a hematoma of the left breast.The hematoma was removed on (b)(6) 2019.The patient received antibiotics from (b)(6) 2019 (cefalexin).The complications resolved without residual effects.

• Brand Name: FORTIVA PORCINE DERMIA
• 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: 9716349
• MDR Text Key: 179615124
• Report Number: 3002924436-2020-00005
• 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,health
• Type of Report: Initial
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: PD18100001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other