MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Catalog Number TVTOBTUNK

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Laceration(s) (1946); Pain (1994); Scarring (2061); Swelling (2091); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that the patient underwent a gynecological procedure on (b)(6) 2010 and mesh was implanted.The patient experienced unspecified punctures or lacerations, a foreign body response, unspecified mesh extrusion, pain, pain during intercourse, neuromuscular problems including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area, recurrence of incontinence, unspecified bleeding, urge incontinence, urinary frequency, atypical vaginal discharge, allergic reaction, swelling around the wound site, recurrent prolapse, vaginal scarring, tightening and/or shortening and constipation/defecation dysfunction.No additional information is available.

Manufacturer Narrative

Date sent to fda: 9/4/2019.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 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 08876-0151 ; 9082182792
• MDR Report Key: 7066924
• MDR Text Key: 93196955
• Report Number: 2210968-2017-71478
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

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 Catalogue Number: TVTOBTUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 09/04/2019
• 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