MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH FORTIVA PORCINE DERMIS

Lot Number PD17210001

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

Patient Problems Erythema (1840); Seroma (2069)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

The graft remains implanted.Serial id number has been requested but not yet provided.A comprehensive records re-review will be conducted and follow up medwatch report will filed once results are available.

Event Description

Rti surgical, inc (rti) and tutogen medical (b)(4) (tmi), a wholly owned subsidiary of rti, received a complaint as part of the fortiva appear trial.The reported complaint indicated that a patient underwent a right nipple conserving inframammary mastectomy with incision on underside of breast on (b)(6) 2019.Two drains were placed (1 in axilla was removed on (b)(6) 2019; second drain was placed in the chest wall over the matrix and removed on (b)(6) 2019).The patient was discharged on (b)(6) 2019 with no additional medications.On (b)(6) 2019, the patient was noticed to have skin redness and a major seroma.Several aspirations were performed (b)(6).The complications were resolved without residual effects.

Manufacturer Narrative

The graft remains implanted.Therefore, a comprehensive records re-review was conducted.There were no departures noted, during records re-review that would negatively impact the manufacturing of xenografts from lot pd17210001.Manufacturing records indicated that serial id (b)(6) met all specifications and release criteria prior to distribution.There is one related complaints for the lot, also associated with the appear trial.Porcine dermis xenografts undergo a validated sterilization method: tutoplast®, which includes terminal sterilization by gamma irradiation after packaging.To date, our investigation indicates, that the reported complications are more likely associated with one or more extrinsic factors, rather than in intrinsic property of the fortiva porcine dermis xenograft.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: PORCINE DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrabe 6; neunkirchen am brand 97077 ; GM 97077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, fl ; 4188888436
• MDR Report Key: 9713161
• MDR Text Key: 179547597
• Report Number: 3002924436-2020-00003
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142070
• 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,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: PD17210001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2020
• 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
• Patient Age: 75 YR
• Patient Sex: Female