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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 07/06/2021
Event Type  Injury  
Manufacturer Narrative
At this time, it is unknown if the graft remains implanted. A comprehensive records re-review is being conducted. Once the results are available, a follow-up report will be submitted.
 
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. On (b)(6)2021, the patient developed a seroma. It is unknown if the seroma was associated with the device and/or the procedure.
 
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Brand NameFORTIVA
Type of DevicePORCINE, DERMIS
Manufacturer (Section D)
TUTOGEN MEDICAL, GMBH
industriestrasse 6
neunkirchen am brand, deu 91077
GM 91077
Manufacturer Contact
karen britt
11621 research circle
alachua 32615
3864188888
MDR Report Key13112949
MDR Text Key284375243
Report Number3002924436-2021-00037
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 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
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 Received11/30/2021
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 Initial

Patient Treatment Data
Date Received: 12/29/2021 Patient Sequence Number: 1
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