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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 MP150701
Device Problems Degraded (1153); Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Capsular Contracture (1761)
Event Date 10/06/2016
Event Type  Injury  
Manufacturer Narrative
Method: (b)(4) conducted a re-review of the product history record for fortiva porcine dermis, packaging production records, environmental monitoring, product specification, distribution database, and the complaint database for related complaint associated with the lot. Results: there were no departures noted during records re-review. The xenograft underwent a validated sterilization methodology. Tutoplast , which includes terminal sterilization by gamma irradiation after packaging. (b)(4) has manufactured and distributed (b)(4) fortiva procine dermis from lot mp150701 without related complaints. Environmental monitoring data generated during and around the time of processing was acceptable. According to records re-review, serial id (b)(4) met all (b)(4) specifications and release criteria prior to distribution. Conclusion: given the facts that: the xenograft underwent a validated sterilization methology, tutoplast, which includes terminal sterilization by gamma irradiation after packaging; serial id (b)(4) met all (b)(4) specifications and release criteria prior to distribution; environmental monitoring data was acceptable; there are no complaints related to the lot associated with infection; and the graft dissolution may be related to a combination of impaired healing and bacterial infection, it is more plausible that the patient's post-operative complications were associated with a source or event extrinsic to the xenograft. Explanted and not available.
 
Event Description
(b)(4), received a complaint which indicated that a patient underwent a revision surgery for capsular contracture after breast reconstruction with implantation of fortiva (unknown lot number and serial number) on (b)(6) 2016. This revision did not achieve aesthetically pleasant results and the patient was complaining of lumps on her right breast. At an unknown date the fortiva graft was removed and another one was implanted in order to support the thin skin. A small fluid leak was noted on the right breast (unknown onset). A revision surgery was performed on (b)(6) 2016, at which time dissolution of the fortiva graft was noted. A culture of the fluid was positive for finegoldia magna. The patient was treated with antibiotics. There were no complications reported regarding the left breast.
 
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Brand NameFORTIVA PORCINE DERMIS
Type of DevicePORCINE DERMIS
Manufacturer (Section D)
TUTOGEN MEDICAL GMBH
industrierstr. 6
neunkirchen am brand, germany 91077
GM 91077
Manufacturer (Section G)
RTI SURGICAL, INC
11621 research circle
alachua FL 32615
Manufacturer Contact
leila kelly
11621 research circle
alachua, FL 32615
3184188888
MDR Report Key6341196
MDR Text Key67801338
Report Number3002924436-2017-00003
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/24/2017
Device Lot NumberMP150701
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2015
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: 02/17/2017 Patient Sequence Number: 1
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