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

Lot Number PD18300001

Device Problem Insufficient Information (3190)

Patient Problem Seroma (2069)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

The batch documentation including the endotoxin test, the individual donor protocol, the ikz protocol, the random sample test and the sterilization certificate were reviewed.A discrepancy was found which, however, had no effect on the complaint graft.According to the documentation, the product was therefore manufactured in accordance with the specification.During the trend analysis, 12 comparable complaints with 13 products were found for the same product code.Since this is not a spontaneous report, but an increase in frequency due to the clinical study, there is no trend.Based on the data received and the inspection of the batch documentation, there is no indication of the unsterility of the affected products.Based on the results of this investigation, it is more plausible that the patient's adverse reaction was associated with a source or event extrinsic to the xengraft implant.

Event Description

Rti surgical, inc (rti) and tutogen medical (b)(4), a wholly subsidiary of rti, received a complaint on 06/30/2021, as part of the fortiva appear trial.The reported complaint indicated that a patient was implanted with a fortiva porcine dermis on (b)(6) 2021 and on an unknown date.On (b)(6) 2021, the patient developed seromas.

• Brand Name: FORTIVA
• Type of Device: PORCINE DERMIS, PRODUCT CODE FTM
• Manufacturer (Section D): TUTOGEN MEDICAL, GMBH; industriestrabe 6; neukirchen am brand,, germany 91077 DEU; GM 91077 DEU
• Manufacturer (Section G): RTI SURGICAL, INC; 11621 reserach circle; alachua FL 32615
• Manufacturer Contact: charity emmons ; 11621 reserach circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 12782828
• MDR Text Key: 282126244
• Report Number: 3002924436-2021-00033
• 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: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/30/2021
• Device Lot Number: PD18300001
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2018
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female