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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/20/2019
Event Type  Injury  
Manufacturer Narrative
The graft remains implanted. Therefore, a comprehensive records re-review was conducted. There were no departures noted during records re-review that would negatively impact the manufacturing of xenografts from lot pd18100001. Manufacturing records indicated that serial id (b)(4) met all specifications and release criteria prior to distribution. There is one related complaint for seroma formation for the lot, also associated with the same physician (name not reported at this time). Porcine dermis xenografts undergo a validated sterilization method: tutoplast®, which includes terminal sterilization by gamma irradiation after packaging. To date, our investigation indicates that the reported complications are more likely associated with one or more extrinsic factors, rather than an intrinsic property of the fortiva porcine dermis xenografts.
 
Event Description
Rti surgical, inc (rti) and tutogen medical gmbh (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 left nipple conserving inframammary mastectomy with incision on the underside of breast. Two drains were placed (one in the axilla removed (b)(6) 2019 and one in chest wall removed (b)(6) 2019. Patient was discharged on (b)(6) 19 with no additional medications. On (b)(6) 2019 the patient was noted to have developed a minor seroma with aspirations performed on (b)(6) 2019 and (b)(6) 2019. The seroma 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 Key9713625
MDR Text Key188685569
Report Number3002924436-2020-00004
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K142070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/14/2020
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 Operator
Device Lot NumberPD18100001
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
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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