MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT RETROPUBIC DEVICE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810041BL

Device Problem Migration (4003)

Patient Problems Adhesion(s) (1695); Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Prolapse (2475); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh was implanted.It was reported that patient underwent exam under anesthesia, transvaginal urethral lysis due to voiding dysfunction with urinary retention status post prolapse and sling surgery on (b)(6) 2011.It was reported that patient underwent exploratory laparotomy, bso, right ureterolysis, abdominal trachelectomy with removal of sacrocolpopexy mesh, retropubic exploration with removal of retropubic sling mesh arms and intentional cystotomy with placement of suprapubic catheter and bilateral indwelling double-j ureteral stents on (b)(6) 2014.It was reported that she experienced pain, erosion of her internal bodily tissue, infection, bleeding, cystocele, rectocele, incontinence and adhesion.No additional information was provided.

Manufacturer Narrative

(b)(4).This emdr represents supplemental report # 2210968-2015-14517 for previously submitted mdr number 2210968-2015-13467, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT RETROPUBIC DEVICE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12580397
• MDR Text Key: 281333873
• Report Number: 2210968-2021-09187
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

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: 09/30/2012
• Device Catalogue Number: 810041BL
• Device Lot Number: 3365783
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 76