MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH FORTIVA PROCINE DERMIS; PORCINE DERMIS

Model Number	PD2025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Infection (1930); Hernia (2240)
Date of Event	10/09/2018
Type of Reportable Event	Serious Injury
Additional 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 "manufaturing" records, sterilization run reports, quality control / assurance reviews and release, and the complaint database for related complaints and trending analysis.Once results are available, a follow up report will be submitted.
Event or Problem Description
Rti surgical, inc (rti) received a complaint notification on (b)(4) 2018 indicating that a patient underwent hernia repair with implantation of a fortiva porcine dermis graft (patient enrolled in a (b)(6) clinical study) on (b)(6) 2017.The patient presented to the emergency department on (b)(6) 2018 with left lower quadrant pain and shortness of breath.A ct scan of the abdomen/pelvis showed a ruptured sigmoid diverticulum.Patient was admitted to the hospital with diverticulitis for antibiotic therapy and pain control.She was treated with ertapenem, cipro and flagyl.To date, rti has not received any additional information.

• Brand Name: FORTIVA PROCINE DERMIS
• Common Device Name: PORCINE DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestr 6; neunkirchen, 91077 ; GM 91077
• MDR Report Key: 8094910
• Report Number: 3002719998-2017-00015
• Device Sequence Number: 1987496
• Product Code: FTM
• UDI-Device Identifier: 04041543312065
• UDI-Public: (01)04041543312065(17)180731(10)MP152001
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: PD2025
• Device Catalogue Number: PD2025
• Device Lot Number: MP152001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other