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

Catalog Number PFRA01

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Erosion (1750)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.The patient demographic info: age, gender, weight, bmi at the time of index procedure the initial approach for the index surgical procedure? date and name of index surgical procedure the diagnosis and indication for the index surgical procedure? were there any concomitant procedures performed? were there any intra-operative complications? what were current symptoms following the index surgical procedure? onset date? was the exposed mesh excised? other relevant patient history/concomitant medications if applicable, will product be returned, return date, tracking information are any pictures available for evaluation? what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient¿s current status?.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and mesh was implanted.Following the procedure, the patient experienced vaginal mesh erosion and post-menopausal bleeding.On (b)(6) 2018, 2 cm x 2 cm of exposed mesh was found on the anterior wall of the vagina, midline at level of bladder neck.A cystoscopy was performed on (b)(6) 2018 and no mesh was found in the bladder.Additional information has been requested.

• Brand Name: ANTERIOR PELVIC FLOOR REPAIR S
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8035225
• MDR Text Key: 126064549
• Report Number: 2210968-2018-76909
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2018

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: 01/31/2012
• Device Catalogue Number: PFRA01
• Device Lot Number: 3270114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention