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

Lot Number NOT PROVIDED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Capsular Contracture (1761); 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) 2020. An adverse event was reported through a post market survey for tutomesh® for breast reconstruction application via qualtrics survey software. The doctor indicated that in her experience using the product, 5-10% of the cases/patients have experienced post-operative development of seroma, 1-5% of the cases/patients have experienced capsular contraction, and 1-5% have experienced adhesions. To date, no additional information has been provided.

• Brand Name: TUTOMESH®
• Type of Device: BOVINE PERICARDIUM MEMBRANE
• Manufacturer (Section D): TUTOGEN MEDICAL, GMBH; industriestrabe 6; neunkirchen am brand 97077 ; GM 97077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, fl ; 4188888436
• MDR Report Key: 9836653
• MDR Text Key: 188687926
• Report Number: 3002924436-2020-00012
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2020
• 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: 03/16/2020 Patient Sequence Number: 1