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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 PD19400001
Device Problem Insufficient Information (3190)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 09/14/2021
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 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 Key12666196
MDR Text Key277438987
Report Number3002924436-2021-00030
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 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberPD19400001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/30/2021
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/20/2021 Patient Sequence Number: 1
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