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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH TUTOMESH SURGICAL MESH

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TUTOGEN MEDICAL GMBH TUTOMESH SURGICAL MESH Back to Search Results
Lot Number NOT PROVIDED
Device Problem Insufficient Information (3190)
Patient Problems Granuloma (1876); Failure of Implant (1924); Inflammation (1932); 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) 2021. An adverse event was reported through a post market survey for tutomesh® for hernia repair application via qualtrics survey software. The survey indicated that doctor (b)(6) has approximately 25 years' experience with the product, 10-20 cases/year and 10% of procedures are laparoscopic. The product meets his expectations. He indicated that he has experienced granuloma and seroma formation, recurrence of hernia and inflamation. Additional information has been requested. To date, no additional information has been received.
 
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Brand NameTUTOMESH
Type of DeviceSURGICAL MESH
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 Key11863510
MDR Text Key255954807
Report Number3002924436-2021-00016
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
Type of Report Initial
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
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 Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/21/2021 Patient Sequence Number: 1
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