MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH TUTOMESH; SURGICAL MESH

Lot Number NOT PROVIDED

Device Problem Insufficient Information (3190)

Patient Problems Granuloma (1876); Seroma (2069); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 10 years' experience with the product, 10 cases/year and 10% of procedures are laparoscopic.The product meets his expectations.He indicated that he has experienced slow resorption, granuloma and seroma formation and recurrence of hernia.To date, additional information has not been provided.

• 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
• MDR Report Key: 11837694
• MDR Text Key: 255955234
• Report Number: 3002924436-2021-00013
• 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: Physician
• Type of Report: Initial
• Report Date: 05/17/2021

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 Number: NOT PROVIDED
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/17/2021
• 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 Number: 1
• Patient Outcome(s): Other