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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH TUTOMESH BOVINE PERICARDIUM SURGICAL MESH

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TUTOGEN MEDICAL GMBH TUTOMESH BOVINE PERICARDIUM SURGICAL MESH Back to Search Results
Lot Number NOT PROVIDED TO DATE
Device Problem Degraded (1153)
Patient Problems Death (1802); Sepsis (2067)
Event Type  Death  
Manufacturer Narrative
Methods: rti/tmi will conduct a re-review of the product history for tutomesh bovine pericardium, packaging production records, environmental monitoring and distribution information for related complaints associated with the lot, once unique identifiers are provided.
 
Event Description
Rti surgical, inc (rti) and tutogen medical (b)(4) (tmi), a wholly owned subsidiary of rti, received a complaint on (b)(6) 2017 which indicated that a patient was implanted with a tutomesh implant as an abdominal closer after bowel perforation. Two days later, the surgeon found out that the mesh was partially disintegrated. Five days after implantation, the patient died of septic shock. Additional information has been requested. To date, rti has not received any additional information.
 
Manufacturer Narrative
Product identifiers were not provided. Therefore, a comprehensive re-review of records could not be conducted. Degradation of the product within this short period of time (2 days), could only be caused by a massive inflammatory response, which is either triggered by a massive infection or the result of an allergic reaction to the bovine product.
 
Event Description
Additional information was provided on 09/22/2017. The patient had not been tested for allergy associated with bovine products. Therefore, it is unknown if the patient was allergic to bovine products. The abdominal wound was covered with jelonet sheet one layer (unknown if after implantation of the tutomesh or after removal). Blood tests for inflammation markers and microbiological analysis were performed. Results were not provided for review. After removal of the tutomesh at an unknown date, a dynamesh (manufacturer unknown) was implanted.
 
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Brand NameTUTOMESH BOVINE PERICARDIUM
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
TUTOGEN MEDICAL GMBH
neunkirchen am brand,
GM
Manufacturer (Section G)
RTI SURGICAL, INC
11621 reasearch circle
alachua FL 32615
Manufacturer Contact
leila kelly
11621 research circle
alachua, FL 32615
3864188888
MDR Report Key6789100
MDR Text Key82519714
Report Number3002924436-2017-00011
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeTC
PMA/PMN Number
K081538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Lot NumberNOT PROVIDED TO DATE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2017
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/11/2017 Patient Sequence Number: 1
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