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

Lot Number PD18480001

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Seroma (2069)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

The grafts remain implanted.Therefore, our investigation is based on a comprehensive records re-review.Once the investigation is completed and results available, a follow up report will be submitted.

Event Description

Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly owned subsidiary of rti, received a complaint as part of the fortiva appear trial.The reported complaint indicated that a patient with history of stage 0 breast cancer underwent a nipple removing, skin sparing mastectomy with breast reconstruction.Two fortiva porcine dermis grafts were implanted on (b)(6) 2020 (serial ids (b)(4) on the left side and (b)(4) on the right side).This report pertains to serial id (b)(4).On (b)(6) 2020 the patient developed pain and seroma formation.The information provided indicated that a 200ml and an 80ml seroma were drained.It is unknown at this time if the patient developed the seromas in one breast or bilaterally.The seromas resolved after drainage.

Manufacturer Narrative

Rti received updated information that stated serial id (b)(6), that was initially reported as being implanted, was documented in error.Only one fortiva graft with the serial id (b)(6) was implanted (med watch report 3002924436-2021-00018).

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrabe 6; neunkirchen am brand, 91077 ; GM 91077
• Manufacturer Contact: karen britt ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 12125514
• MDR Text Key: 260991926
• Report Number: 3002924436-2021-00017
• 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: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: PD18480001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 42 YR
• Patient Sex: Female