MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 2INX12IN; MESH, SURGICAL, POLYMERIC

Model Number	PMXL
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Fistula (1862); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Perforation (2001); Burning Sensation (2146); Distress (2329); Obstruction/Occlusion (2422)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Do you know the product code or lot number of the ethicon mesh used? if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).This medwatch report is in response to receipt of maude event report: mw5113272.
Event or Problem Description
It was reported that a patient underwent a pelvic organ prolapse with transabdominal procedure on an unknown date in 2008 and mesh was implanted.The patient reported that the infected mesh was found to have eroded into the bowel causing a fistula and the bowel to perforate.Following the procedure, the patient reported waking up with an ileostomy bag which was reported to be given to her to save her life.The patient further reported spending a month in the hospital after that surgery.About four days after discharge, the patient reported that her body rejected a colonic stent that was put in to help with widening colon until ileostomy bag could be reversed.The patient spent another week in the hospital after that.The patient had the ileostomy bag for five months and reported non-stop stoma burns from the way the ileostomy was situated and also had a very high output bag.The patient underwent reversal of ileostomy on an unknown date and spent over a week and a half in the hospital.The patient reported being admitted again with pain and found out there was a blockage and other unspecified concerns.The blockage was treated in hospital and it was then decided to perform an open low anterior resection with a portion of rectum removal for a contained rectal perforation and pelvic pain.The patient reported being in the hospital again for a month.The patient is still in pain, taking gabapentin 900 mg x 3, experiencing bladder incontinence and is scheduled for a sigmoidoscopy for bowel voiding issues.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: 3/1/2023.Additional information: a1, a3, d1, d4, e1 date sent to the fda: 3/1/2023.Corrected information: g4 (510k).
Additional Manufacturer Narrative
Date sent to the fda: 3/23/2023.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PROLENE MESH 2INX12IN
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15978029
• Report Number: 2210968-2022-10253
• Device Sequence Number: 20298226
• Product Code: FTL
• UDI-Device Identifier: 10705031049062
• UDI-Public: 10705031049062
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: PMXL
• Device Catalogue Number: PMXL
• Device Lot Number: XLB885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 02/23/2023; 03/13/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 03/01/2023; 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female