MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH TUTOMESH; BOVINE PERICARDIUM MEMBRANE

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Seroma (2069); Fibrosis (3167)

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 breast reconstruction.The survey indicated that the doctor (b)(6) (15 years' experience with the product; 10-20 cases/year), has experienced the following post-operative complications: infections, slow resorption and radiation induced fibrosis in less than 1% of cases; seroma formation in 1-5 % of the cases additional information has been requested.To date, no additional information has been received.

• 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 Key: 11519206
• MDR Text Key: 247263767
• Report Number: 3002924436-2021-00004
• 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: 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 Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/18/2021
• 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 Number: 1
• Patient Outcome(s): Other