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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 UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem Seroma (2069)
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.The survey indicated that the dr.(b)(6) (5 years experience with the product; less than 10 cases/year), has experienced the following post-operative complications: red breast syndrome, seroma formation and slow resorption in less than 1% of cases.The physician indicated in the survey that the radiation induced fibrosis has improved due to the use of tutomesh.Additional information has been requested.To date, no additional information has been received.
 
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Brand Name
TUTOMESH
Type of Device
BOVINE PERICARDIUM MEMBRANE
Manufacturer (Section D)
TUTOGEN MEDICAL, GMBH
industriestrabe 6
neunkirchen am brand, 91077
GM  91077
Manufacturer Contact
leila kelly
11621 research circle
alachua, FL 32615
3864188888
MDR Report Key11519853
MDR Text Key243127863
Report Number3002924436-2021-00005
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K081538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/18/2021
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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