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

Catalog Number PCDG1

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

Patient Problems Pain (1994); Scarring (2061); Cramp(s) (2193)

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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. (b)(4) submitted for adverse event which occurred on (b)(6) 2012. (b)(4) submitted for adverse event which occurred on (b)(6) 2017.

Event Description

It was reported by an attorney that the patient underwent incisional hernia repair surgery on (b)(6) 2009 and mesh was implanted. It was reported that the patient underwent partial excision on (b)(6) 2012 during which the surgeon noted a portion of the mesh had come into the bladder. Some of the mesh was destroyed by the laser fiber, and some had to be pulled off and separated from the bladder. It was reported that the patient underwent removal of the remaining mesh on (b)(6) 2017 during which the surgeon noted mesh adherent to the bladder wall, which was dissected and removed. It was reported that the patient experienced severe pain, organ damage, mesh migration, cramping, scarring, inflammation, nausea, stress and anxiety. No additional information is provided.

Manufacturer Narrative

Date sent to fda: 8/26/2020. A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to fda: (b)(6) 2020. Corrected information: d7 - from (b)(6) 2012, to empty value since partial removal was done and not full mesh removal.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8847283
• Report Number: 2210968-2019-84875
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/31/2011
• Device Catalogue Number: PCDG1
• Device Lot Number: BKG462
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Required Intervention