MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH TUTOMESH SURGICAL MESH

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.

• Brand Name: TUTOMESH
• Type of Device: SURGICAL 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 Key: 11863510
• MDR Text Key: 255954807
• Report Number: 3002924436-2021-00016
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K081538
• Number of Events Reported: 1
• 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 Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: NOT 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 Received: 04/23/2021
• 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