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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH FORTIVA PORCINE DERMIS SURGICAL MESH

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TUTOGEN MEDICAL GMBH FORTIVA PORCINE DERMIS SURGICAL MESH Back to Search Results
Lot Number MP154501
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seroma (2069); Hernia (2240)
Event Date 05/31/2019
Event Type  Injury  
Manufacturer Narrative
The fortiva porcine dermis remains implanted and not available for evaluation. Therefore, our investigation is based on a comprehensive records re-review for lot mp154501. This will include a re-review of manufacturing records, sterilization run reports, quality control / assurance reviews and release, and the complaint database for related complaints for the lot. Once these results are available, a follow up report will be submitted.
 
Event Description
Rti surgical, inc was notified of a complaint indicating that a patient enrolled in a hernia repair clinical study was implanted with a fortiva porcine dermis graft on (b)(6) 2019. On (b)(6) 2019, the patient developed a seroma. The patient had an indwelling drain. At an unknown date, the drain was imaged under fluoroscopy and was removed because the fluid collection was improved. Additional information has been requested.
 
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Brand NameFORTIVA PORCINE DERMIS
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
TUTOGEN MEDICAL GMBH
industriestrasse 6
neunkirchen am brand 91077
GM 91077
Manufacturer Contact
leila kelly
11621 research circle
alachua, FL 32615
3864188888
MDR Report Key9071513
MDR Text Key158711306
Report Number3002719998-2019-00018
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/30/2019
Device Lot NumberMP154501
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 Received08/16/2019
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: 09/16/2019 Patient Sequence Number: 1
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