MAUDE Adverse Event Report: ETHICON INC. GYNECARE GYNEMSH PS 4INX6IN; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number	GPSL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Incontinence (1928); Neuropathy (1983); Pain (1994); Urinary Frequency / Polyuria (2275); Discomfort (2330); Numbness (2415); Prolapse (2475); Ambulation or Postural Difficulties (2544); Unspecified Kidney or Urinary Problem (4503); Insufficient Information (4580)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a rectopexy, cystopexy and hysteropexy surgery using promoto-fixation following grade iv rectal prolapse associated with cervico-cystoptosis and hysterocele on (b)(6) 2020 and mesh was implanted.The anterior and posterior promoto-fixation operation included placement of the mesh on the anterior vaginal wall with7 autosure endouniversal staples and on the isthmus with 2 ethibond 0 stitches + insertion of a gynemeche of 15/5 cm fixed to the levator muscles on the anterior face of the rectum by endo-hernia.Fixation of the 2 prostheses to the promontory using capsure and closure of the peritoneal breach using v-loch 3/0.First rheumatological/neuropathic pathology diagnosed in 2021 via spinal mri following a visit to emergency with degenerative disc disease and discarthrosis, c4/c5, c5/c6, c6/c7, l5s1.The patient could hardly walk or drive without very quickly feeling tingling, numbness, paresthesia and intense pain.He is regularly bent double with neuropathic pain associated with neck pain, back pain and lower back pain.He has to walk with a crutch or cane regularly, when he is not paralyzed, especially on the left side, legs and arms.He has to give up driving because of the danger associated with the pain and motor problems in his legs and arms.He tried physiotherapy and began hospitalization in a rehabilitation center which had to be interrupted because of disabling motor pain and discomfort, making it impossible to take care of him.Use of the tens system.Inability to take painkillers, anti-inflammatories, corticoids, muscle relaxants due to gastrointestinal pathology aggravated by the side effects of these drugs.The patient further reported during a second gastro-enterological pathology, following rectopexy, worsening of constipation in the form of incapacitating dyschesia associated with daily abdominal and pelvic pain, worsening of the pain associated with ovarian endometriosis.At present, the patient is experiencing terminal constipation with daily trans-anal irrigation, via the peristeen system after failure of other treatments.Recurrence of cystocele linked to terminal constipation.Pollakiuria, bladder hyperactivity, mixed urinary incontinence, pelvic heaviness.Hypokalliaemia related to trans-anal irrigations (2 recent visits to the emergency department of the chu for generalized muscular contractions due to lack of potassium).No further information is available as the reporter contact details were not disclosed.
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.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.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

• Brand Name: GYNECARE GYNEMSH PS 4INX6IN
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19637790
• Report Number: 2210968-2024-06780
• Device Sequence Number: 8794009
• Product Code: OTO
• UDI-Device Identifier: 10705031037731
• UDI-Public: 10705031037731
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 11/30/2024
• Device Catalogue Number: GPSL
• Device Lot Number: PPBCLH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown