MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

Model Number PCDN1

Device Problem Migration (4003)

Event Type  Injury  

Manufacturer Narrative

To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2017 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted, he found exposed mesh with a purulent pocket.A full dissection was carried out through the scar tissue.I gained entrance into the abdominal cavity as i opened up the fascia superior to the exposed mesh.Lysis of adhesions was now carried out.We found a couple of loops of small bowel here to underside of the mesh.These were carefully dissected off the mesh.Small area of the serosal lysed small bowel was repaired.I was now able to excise around the mesh cutting out the abdominal wall to include all of the mesh.It was reported that the patient experienced severe pain and inflammation.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 5/11/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: 7/14/2022.Additional b5 narrative: it was reported that the patient experienced infection and abscess following surgery.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13814766
• MDR Text Key: 291476312
• Report Number: 2210968-2022-01903
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047761
• UDI-Public: 10705031047761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: PCDN1
• Device Catalogue Number: PCDN1
• Device Lot Number: LDG172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 03/18/2022
• Supplement Dates Manufacturer Received: 05/11/2022; 07/13/2022
• Supplement Dates FDA Received: 05/11/2022; 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female