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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 PD18440001
Device Problem Insufficient Information (3190)
Patient Problem Swollen Lymph Nodes/Glands (4432)
Event Date 12/13/2021
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
On 03/16/2022, rti surgical, inc. And tutogen medical (b)(4), a wholly subsidiary of rti surgical, received a complaint as part of the fortiva appear trial. The reported complaint indicated that on (b)(6) 2020, the patient underwent a left breast reconstruction post-mastectomy, removal of three lymph nodes on the left side, and implantation of a fortiva dermal graft. A silicone implant and two drains were also placed. On (b)(6) 2021, the patient had developed lymphoedema on the left side. It is unknown if the adverse event is associated to the graft or to the procedure. To date, no additional information has been provided for review.
 
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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, FL 32615
3864188888
MDR Report Key14115593
MDR Text Key289348891
Report Number3002924436-2022-00005
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 05/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Expiration Date05/31/2022
Device Lot NumberPD18440001
Was Device Available for Evaluation? No
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/30/2019
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: 04/14/2022 Patient Sequence Number: 1
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