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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 PD17210001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Seroma (2069)
Event Date 09/16/2019
Event Type  Injury  
Manufacturer Narrative
The graft remains implanted. Serial id number has been requested but not yet provided. A comprehensive records re-review will be conducted and follow up medwatch report will filed once results are available.
 
Event Description
Rti surgical, inc (rti) and tutogen medical (b)(4) (tmi), a wholly owned subsidiary of rti, received a complaint as part of the fortiva appear trial. The reported complaint indicated that a patient underwent a right nipple conserving inframammary mastectomy with incision on underside of breast on (b)(6) 2019. Two drains were placed (1 in axilla was removed on (b)(6) 2019; second drain was placed in the chest wall over the matrix and removed on (b)(6) 2019). The patient was discharged on (b)(6) 2019 with no additional medications. On (b)(6) 2019, the patient was noticed to have skin redness and a major seroma. Several aspirations were performed (b)(6). The complications were resolved without residual effects.
 
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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 
4188888436
MDR Report Key9713161
MDR Text Key179547597
Report Number3002924436-2020-00003
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K142070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberPD17210001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/14/2020 Patient Sequence Number: 1
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