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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 PD19360001
Device Problem Insufficient Information (3190)
Patient Problems Hemorrhage/Bleeding (1888); Necrosis (1971); Seroma (2069); Impaired Healing (2378); Needle Stick/Puncture (2462)
Event Date 08/27/2021
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 study. The complaint indicated that the patient underwent a surgical procedure, on an unknown date, with implantation of an rti fortiva graft. On (b)(6) 2021, the patient developed bleeding.
 
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Brand NameFORTIVA
Type of DevicePORCINE, DERMIS
Manufacturer (Section D)
TUTOGEN MEDICAL, GMBH
industriestrasse 6
neunkirchen am brand
deu, germany 91077
GM 91077
Manufacturer (Section G)
RTI SURGICAL, INC
11621 research circle
alachua FL 32615
Manufacturer Contact
karen britt
11621 research circle
alachua, FL 32615
3864188888
MDR Report Key12658554
MDR Text Key277208134
Report Number3002924436-2021-00027
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberPD19360001
Was Device Available for Evaluation? No
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/30/2021
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: 10/19/2021 Patient Sequence Number: 1
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