MAUDE Adverse Event Report: ETHICON INC. POSTERIOR PELVIC FLOOR REPAIR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRP01

Device Problem Migration (4003)

Patient Problems Abdominal Pain (1685); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Discomfort (2330); Fibrosis (3167)

Event Type  Injury  

Event Description

The event was reported by an attorney having received email contact from a senior associate at a (b)(6) law firm regarding a potential case.It was reported that a mesh product was inserted at (b)(6) hospital on (b)(6) 2012.The legal firm is requesting the manufacture and supply dates.No further details relating to the nature of the complaint have been provided at this time.It is reported in the summons that the complainant had a previous anterior and posterior vaginal prolapse repair in 2003 but had become aware of symptoms of pressure in the pelvis, frequency of micturition occasional problems with bowel motions.It was noted that she had a rectocele and cystocele.She underwent an anterior pelvic floor repair and posterior prolift pelvic floor repair in (b)(6) 2012.Following the procedure she noted discomfort and felt a bulge, this didn¿t settle and she was noted to be very tender at the apex of the mesh.There was no erosion but induration of the area was noted.In (b)(6) 2013 she underwent an excision of the prolift mesh and a posterior floor repair.No additional information was provided.

Manufacturer Narrative

This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2015-02673, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.The information included in this report was submitted outside the required timeframe due to the extended use of exemption e2013037 beyond its revoke date, as documented under ha(b)(4) (ethicon¿s internal reference number).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.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.

• Brand Name: POSTERIOR PELVIC FLOOR REPAIR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12833374
• MDR Text Key: 286055928
• Report Number: 2210968-2021-11630
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2020

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: 08/31/2012
• Device Catalogue Number: PFRP01
• Device Lot Number: 3355199
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• 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 Sex: Female