MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH FORTIVA PORCINE DERMIS

Lot Number NOT PROVIDED

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

Patient Problems Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

The information provided to date indicated that the xenograft remains implanted and not available for evaluation.Therefore, a comprehensive re-review will be conducted of the manufacturing records, sterilization run reports, environmental monitoring results, quality control / assurance reviews and release, and the complaint database for related complaints, once the unique identifiers are provided to rti.

Event Description

Rti surgical, inc (rti) received a complaint notification on 08/22/2017 indicating that a patient underwent implantation of a fortiva porcine dermis on an unknown date, as part of a hernia repair clinical study.The patient developed a post-operative wound infection on (b)(6) 2016 and a seroma on (b)(6) 2016 (unknown specific location).Additional information has been requested.To date, rti has not received any additional information.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: PORCINE DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestr 6; neunkirchen, germany 91077 ; GM 91077
• Manufacturer (Section G): RTI SURGICAL, INC; 11621 research circle; alachua FL 32615
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 6870740
• MDR Text Key: 86410025
• Report Number: 3002719998-2017-00027
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142070
• 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: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2017
• 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