MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2003 and a mesh was implanted due to pop.The patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient experienced pain, infection, urinary problems, organ perforation, recurrence, dyspareunia, and vaginal scarring.It was reported that the patient has undergone multiple surgeries and revisionary procedures.It was reported that the patient underwent a laparoscopic lysis of adhesions, double fill cystoscopy on (b)(6) 2008 due to chronic pelvic pain, abdominal pain, and dyspareunia.The patient underwent a laparoscopy with lysis of adhesions of bowel, fulguration of adhesions, paravaginal defect repair, burch urethropexy , revision of sling, cystourethroscopy with hydrodistention, repair of rectocele with colporrhaphy and perineorrhaphy, porcine graft implant, vaginal packing on 2013 due to pelvic pain, sui, urinary frequency, failed bladder tack, symptomatic rectocele, adhesion.The patient underwent an incision for implantation of tined quadripolar lead electrodes, s3 foramen fluoroscopic guidance for needle placement, subcutaneous placement of sacral nerve stimulater on (b)(6) 2013 due to urinary urgency, frequency, retention, recalcitrant to medical management and anatomic repair.The patient underwent a bladder stimulation removal and reinsertion on (b)(6) 2013 due to urinary frequency and urgency.No additional information was provided.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

(b)(4): it was reported that the patient concurrently underwent cystoscopy.It was reported that following insertion the patient experienced stress incontinence, hypermobile urethral junction, paravaginal defect, urinary frequency, urgency, failed prior bladder tack, adhesions, and symptomatic rectocele.It was reported that the patient underwent revision/removal of sling on (b)(6) 2013 by dr.(b)(6).

• Brand Name: GYNECARE MESH UNKNOWN
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4617932
• MDR Text Key: 5702454
• Report Number: 2210968-2015-03283
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2016

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 03/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 31 YR