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U.S. Department of Health and Human Services

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

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TUTOGEN MEDICAL, GMBH FORTIVA PORCINE DERMIS Back to Search Results
Lot Number PD18300001
Device Problem Insufficient Information (3190)
Patient Problem Seroma (2069)
Event Date 09/22/2021
Event Type  Injury  
Event Description
Rti surgical, inc. And tutogen medical gmbh (tmi), a wholly subsidiary of rti surgical, received a complaint as part of the fortiva appear trial. The reported complaint indicated that the patient underwent a surgical procedure on an unknown date with implantation of a fortiva graft. On (b)(6) /2021, the patient developed a seroma that was associated with the device and procedure.
 
Manufacturer Narrative
At this time it is unknown if the graft remains implanted. A comprehensive records re-review will be conducted. Once the results are available, a follow-up report will be submitted.
 
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Brand NameFORTIVA
Type of DevicePORCINE DERMIS
Manufacturer (Section D)
TUTOGEN MEDICAL, GMBH
industriestrasse 6
neunkirchen am brand, germany
GM
Manufacturer Contact
karen britt
11621 research circle
alachua, FL 32615
3864188888
MDR Report Key12963698
MDR Text Key284375098
Report Number3002924436-2021-00035
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 Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
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
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/08/2021 Patient Sequence Number: 1
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