MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT OBURATOR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Irritation (1941); Laceration(s) (1946); Pain (1994); Scarring (2061); Abnormal Vaginal Discharge (2123); No Code Available (3191)

Event Date 02/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown repair procedure for incontinence on (b)(6) 2009 and the mesh was implanted.Following the procedure, the patient experienced lacerations of vagina requiring surgical repair, transitory local irritation at the wound site, a foreign body response to mesh extrusion, exposure, and erosion into the vagina, acute and chronic back and pelvis pain, voiding dysfunction, pain during intercourse, atypical vaginal discharge, exposed mesh causing pain and discomfort during intercourse, mesh migration, allergic reaction, vaginal scarring, tightening and shortening, constipation/defecation dysfunction, granulation tissue formation.The patient also underwent a revision procedure due to lacerations in the vaginal vault on (b)(6) 2017.No further information is available.

• Brand Name: GYNECARE TVT OBURATOR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6578196
• MDR Text Key: 75539239
• Report Number: 2210968-2017-03760
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2017

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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