MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH FORTIVA PORCINE DERMIS SURGICAL MESH

Lot Number MP154501

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

Patient Problems Seroma (2069); Hernia (2240)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

The fortiva porcine dermis remains implanted and not available for evaluation. Therefore, our investigation is based on a comprehensive records re-review for lot mp154501. This will include a re-review of manufacturing records, sterilization run reports, quality control / assurance reviews and release, and the complaint database for related complaints for the lot. Once these results are available, a follow up report will be submitted.

Event Description

Rti surgical, inc was notified of a complaint indicating that a patient enrolled in a hernia repair clinical study was implanted with a fortiva porcine dermis graft on (b)(6) 2019. On (b)(6) 2019, the patient developed a seroma. The patient had an indwelling drain. At an unknown date, the drain was imaged under fluoroscopy and was removed because the fluid collection was improved. Additional information has been requested.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrasse 6; neunkirchen am brand 91077 ; GM 91077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 9071513
• MDR Text Key: 158711306
• Report Number: 3002719998-2019-00018
• 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

• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/30/2019
• Device Lot Number: MP154501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/16/2019
• 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: 09/16/2019 Patient Sequence Number: 1