MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT OBTURATOR W LASR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810081L

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 07/06/2017.The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure date of initial procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications product code and lot number? what is physician¿s opinion as to the etiology of or contributing factors to this event any concurrent procedure/device implantation? when was the mesh exposure first noted by a physician? mesh exposure location, symptoms and diagnostic confirmation? describe any medical/surgical intervention for exposure including dates and results.What is the patient¿s current status?.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on unknown date and the mesh was implanted.Following the procedure, the patient experienced mesh erosion and bladder stone formation.Additional information has been requested.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• 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: 6690308
• MDR Text Key: 79175845
• Report Number: 2210968-2017-04371
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2009
• Device Catalogue Number: 810081L
• Device Lot Number: 3182117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2008
• 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