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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 Problems Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971)
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 (b)(4) (tmi), a wholly subsidiary of rti, received a complaint on 02/16/2021. An adverse event was reported through a post market survey for tutomesh® for breast reconstruction application. The survey indicated that dr. (b)(6) (around 5 years' experience with the product; 20+ cases/year), has experienced the following post-operative complications: implant loss, infections, inflammation and red breast syndrome in less than 1% of cases; and skin flap necrosis in 1-5% of cases. Additional information has been requested. 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, 91077
GM 91077
Manufacturer Contact
leila kelly
11621 research circle
alachua, FL 32615
3864184408
MDR Report Key11518609
MDR Text Key246974570
Report Number3002924436-2021-00002
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K081538
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 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2021
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 Unkown

Patient Treatment Data
Date Received: 03/18/2021 Patient Sequence Number: 1
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