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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 PD18100001
Device Problem Insufficient Information (3190)
Patient Problem Capsular Contracture (1761)
Event Date 09/16/2021
Event Type  Injury  
Manufacturer Narrative
It is unknown at this time if the graft remains implanted. A comprehensive records re-review will be conducted. Once results are available, a follow-up will be submitted.
 
Event Description
Rti surgical, inc and tutogen medical (b)(4) (tmi), a wholly subsidiary of rti, received a complaint on (b)(6) 2021, as part of the (b)(6) trial. The reported complaint indicate that the patient (subject (b)(6)) underwent a breast reconstruction on (b)(6) 2021 with implantation of fortiva porcine dermis and developed a capsular contracture.
 
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Brand NameFORTIVA
Type of DevicePORCINE DERMIS
Manufacturer (Section D)
TUTOGEN MEDICAL, GMBH
industriestrabe 6
neunkirchen am brand,, germany 91077
GM 91077
Manufacturer (Section G)
TUTOGEN MEDICAL, GMBH
industriestrabe 6
neunkirchen am brand, germany 91077 DEU
GM 91077 DEU
Manufacturer Contact
charity emmons
11621 reserach circle
alachua, FL 32615
3864188888
MDR Report Key12672913
MDR Text Key277679906
Report Number3002924436-2021-00031
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 Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Expiration Date10/31/2021
Device Lot NumberPD18100001
Was Device Available for Evaluation? No
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/30/2018
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: 10/21/2021 Patient Sequence Number: 1
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