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U.S. Department of Health and Human Services

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

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TUTOGEN MEDICAL, GMBH FORTIVA PORCINE DERMIS, PRODUCT CODE FTM Back to Search Results
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.
 
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Brand NameFORTIVA
Type of DevicePORCINE 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 Key12782828
MDR Text Key282126244
Report Number3002924436-2021-00033
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Company Representative
Reporter Occupation
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 Received11/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Expiration Date11/30/2021
Device Lot NumberPD18300001
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received06/30/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/31/2018
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 11/09/2021 Patient Sequence Number: 1
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