MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH TUTOPATCH BOVINE PERICARDIUM; SURGICAL MESH

Model Number NOT PROVIDED

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Inflammation (1932); Swelling (2091)

Event Date 07/17/2014

Event Type  Injury  

Event Description

Rti surgical, inc.And tutogen medical (b)(6) a wholly owned subsidiary of rti, received a complaint of post-operative graft at the nasal dorsum following an open rhinoplasty procedure performed on (b)(6) 2014.On (b)(6) 2014, the pt returned for f/u without complications noted.Approx 2 days later, the pt developed redness over the nose and into the weekend developed facial swelling (eyes and jowls) with no fever or symptoms of infection noted.The pt was prescribed steroids and antibiotic therapy.On (b)(6) 2014, the pt underwent a revision procedure.

Manufacturer Narrative

Investigation: the graft was sent for histopathological review.Mfg records re-review was also conducted.Investigation results: results of histopathologic review consistent with a chronic inflammatory response and hypersensitivity reaction.No deviations were noted during the mfg records re-review for lot# nz12390137.The graft underwent a validated sterilization method: tutoplast which includes gama irradiation after packaging.To date, rti has distributed 43 grafts from the lot without related complaints.According to the mfg records, label id 000000012738053 was manufactured to spec prior to distribution.Conclusion: although implant therapy is highly successful and predictable, it is not without possible early and/or late complications.Communication with the physician documented the pt had an allergic reaction to the graft with no evidence of infection noted.

• Brand Name: TUTOPATCH BOVINE PERICARDIUM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; neunkirchen an brand ; GM
• Manufacturer (Section G): TUTOGEN MEDICAL GMBH; GM
• Manufacturer Contact: karen britt ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 4085135
• MDR Text Key: 4857921
• Report Number: 3002924436-2014-00003
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K081538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: 68351
• Device Lot Number: NZ12390137
• Other Device ID 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: 07/23/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR