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

Catalog Number PCDJ1

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

Patient Problems Abscess (1690); Adhesion(s) (1695); Inflammation (1932); Ischemia (1942); Nausea (1970); Pain (1994); Scar Tissue (2060); Vomiting (2144); Chills (2191); Deformity/ Disfigurement (2360); Decreased Appetite (4569)

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

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2010 and mesh was implanted.It was reported that the patient underwent small bowel resection and extensive lysis of adhesions on (b)(6) 2017.It was reported the patient underwent partial mesh removal on (b)(6) 2017.It was reported that the patient underwent surgical procedures on (b)(6) 2017 and (b)(6) 2017.It was reported that the patient experienced severe pain, adhesions, abscess, severely dilated and ischemic colon, nausea, vomiting, chills, inflammation, scarring, disfigurement, loss of appetite, stress and anxiety.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 2/22/2021.Additional information: d1, d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11313361
• MDR Text Key: 234271253
• Report Number: 2210968-2021-01313
• 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
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: PCDJ1
• Device Lot Number: BKG453
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention