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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Burning Sensation (2146); No Code Available (3191)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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 an unknown procedure on unknown date and the mesh was implanted.It was also reported that on (b)(6) 2015 the mesh was removed as it was causing a foreign body reaction which left the patient's vagina with burning sensation and the patient could not use tampons during her period and had lost a sex life.The patient experienced a pain even after mesh removal and was taking gabapentin and sometimes tramadol.As reported, the patient could not run as it sets off pain that lasts for up to a week.The patient also experienced gerd that has gone since removal.

• Brand Name: GYNECARE TVT
• 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: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6179526
• MDR Text Key: 62521056
• Report Number: 2210968-2016-36756
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974098
• 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: 11/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• 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
• Date Manufacturer Received: 11/28/2016
• 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