MAUDE Adverse Event Report: DSM BIOMEDICAL, INC. TRELLIFORM; SURGICAL MESH

Model Number TF0616

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Fluid Discharge (2686)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

Root cause investigation: product/process review, batch record review, sme interviews to ensure all proper controls were implemented and followed.A review of the 7003779 batch record and its associated intermediate manufacturing processes (pn 6445-41 ln 8003848, pn 6199-04 ln 8003370 and 8003288, pn 6248-04 ln 5000877 and 5002321) confirmed there were no discrepancies associated with the product that could have impacted product performance.Upon review of the risk assessment and current controls in place, it was determined that the controls referenced in the risk analysis remain acceptable and applicable at this time.With a dhf review and risk assessment review being completed, all controls were correctly implemented and there were no discrepancies during manufacturing and no assignable root cause can be determined at this time.

Event Description

It was reported that a female patient of unknown age or weight underwent a cosmetic procedure for primary bilateral breast augmentation with trelliform surgical mesh.Patient has no known underlying medical conditions.Approximately 4 weeks following the original surgery, the patient noted bilateral dehiscence of the surgical sites and a non-odorous secretion of fluid believed to be the breakdown of the mesh.The surgeon reported no seroma or infection and felt that the issue was not a problem with the surgical mesh.No other explanation was given.No cultures of the fluid were obtained.The patient underwent revision surgery to have the surgical mesh removed and is currently doing well with no further complications.

Manufacturer Narrative

Submitting a correction to manufacturer report number 2530154-2020-00001, submitted via esg gateway on april 16, 2020.Updating section g.4, date received by manufacturer from 17-mar-2020 to 13-mar-2020, to accurately reflect the date of manufacturer's awareness that had previously been reported incorrectly due to a typographical error in the complaint management system.

• Brand Name: TRELLIFORM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DSM BIOMEDICAL, INC.; 735 pennsylvania drive; exton, pa
• MDR Report Key: 9968723
• MDR Text Key: 191835631
• Report Number: 2530154-2020-00001
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00081233702372
• UDI-Public: 0081233702372
• Combination Product (y/n): N
• PMA/PMN Number: K091499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF0616
• Device Catalogue Number: 30017-02
• Device Lot Number: 70033779
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2020
• Patient Sequence Number: 1
• Treatment: BREAST IMPLANTS, DEVICE IDENTIFY UNKNOWN
• Patient Outcome(s): Required Intervention