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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 NOT PROVIDED
Device Problem Insufficient Information (3190)
Patient Problem Necrosis (1971)
Event Date 06/02/2020
Event Type  Injury  
Manufacturer Narrative
Unique identifiers have not provided to date in order to conduct a comprehensive records re-review. If additional information becomes available, a follow up report will be submitted.
 
Event Description
Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly subsidiary of rti, received a complaint on (b)(6) 2020, as part of the fortiva appear trial. The reported complaint indicated that a patient was implanted with a fortiva porcine dermis graft on at an unknown date. On (b)(6) 2020, the patient developed skin necrosis. Additional information has been requested.
 
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Brand NameFORTIVA PORCINE DERMIS
Type of DevicePORCINE DERMIS
Manufacturer (Section D)
TUTOGEN MEDICAL GMBH
industriestrabe 6
neunkirchen am brand, 97077
GM 97077
Manufacturer Contact
leila kelly
11621 research circle
alachua, FL 32615
3864188888
MDR Report Key10945328
MDR Text Key219498261
Report Number3002924436-2020-00019
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,health
Reporter Occupation
Type of Report Initial
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2020
Was Device Evaluated by Manufacturer? No
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: 12/04/2020 Patient Sequence Number: 1
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