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

Catalog Number PD3030

Device Problem Contamination (1120)

Patient Problems Wound Dehiscence (1154); Hernia (2240)

Event Date 09/30/2014

Event Type  Injury  

Event Description

Rti surgical, inc.(rti) and tutogen medical (b)(4), a wholly owned subsidiary of rti received a complaint on (b)(6) 2014 reporting that a patient underwent a difficult small bowel repair, a contaminated wound site, with abdominal wall reconstruction utilizing a fortiva graft on (b)(6) 2014.The patient was readmitted on (b)(6) 2014 due to the development of wound dehiscence with graft degradation noted.Medical records were requested but not received.

Manufacturer Narrative

Method: graft was not returned to rti for evaluation, therefore, a re-review was performed of the manufacturing records, sterilization run reports, environmental monitoring results, quality control/assurance reviews and release, and the complaint database for related complaints associated with the lot.Results: no deviations were noted during the records re-review for lot# mp130701.The graft underwent a validated sterilization; tutoplast which includes terminal sterilization by gama irradiation after packaging.To date, rti has distributed (b)(4) xenografts from the lot and distributed (b)(4) without related complaints.Environmental data and records generated during and around the time of processing for lot# mp130701 were acceptable.Conclusion: given that (1) no deviations were noted in records re-review, graft id (b)(6) manufactured to specification prior to distribution, and (2) per physician report in the complaint notification, the graft was utilized in a contaminated wound site, it is more plausible that the patient's outcome and complications were associated with a source or event extrinsic to the xenograft implant.

• Brand Name: FORTIVA PROCINE DERMIS
• Type of Device: PORCINE DERMAL TISSUE
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; neunkirchen ; GM
• Manufacturer (Section G): TUTOGEN MEDICAL GMBH
• Manufacturer Contact: leila diaz ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 4339861
• MDR Text Key: 5198482
• Report Number: 3002924436-2014-00005
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Physician
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2016
• Device Catalogue Number: PD3030
• Device Lot Number: MP130701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2014
• 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
• Patient Sequence Number: 1
• Treatment: NOT PROVIDED
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR