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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUTOGEN MEDICAL, GMBH TUTOMESH® BOVINE PERICARDIUM MEMBRANE

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TUTOGEN MEDICAL, GMBH TUTOMESH® BOVINE PERICARDIUM MEMBRANE Back to Search Results
Lot Number NOT PROVIDED
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Capsular Contracture (1761); Failure of Implant (1924); Necrosis Of Flap Tissue (1972); Seroma (2069); Fibrosis (3167)
Event Type  Injury  
Manufacturer Narrative
Unique identifiers were not provided in order to conduct a comprehensive records re-review. If additional information becomes available, a follow up report will be submitted.
 
Event Description
Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly subsidiary of rti, received a complaint on (b)(6) 2020. An adverse event was reported through a post market survey for tutomesh® for breast reconstruction application via qualtrics survey software. The doctor indicated that in her four years of experience using the product, more than 10% have developed post-operative seromas, more than 5-10% of the cases/patients have experienced post radiation capsular contraction and radiation induced fibrosis, less than 1% have experienced implant loss and skin flap necrosis. To date, no additional information has been received.
 
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Brand NameTUTOMESH®
Type of DeviceBOVINE PERICARDIUM MEMBRANE
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 Key9837005
MDR Text Key188688082
Report Number3002924436-2020-00013
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K081538
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 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2020
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: 03/16/2020 Patient Sequence Number: 1
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