MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT EXACT CONTINENCE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTRL

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2016

Event Type  malfunction  

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 an unknown procedure on (b)(6) 2016 and the mesh was implanted.During the procedure, a box with device was opened and the sterile package was found not sealed.Sterility was compromised and another like package was opened and used to complete the procedure.There were no patient consequences reported.No further information is available.

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The complaint form did not indicate if the device/packaging reported in this event would be returned for evaluation.Please tell us if the product/packaging will be returned for evaluation.

Manufacturer Narrative

The entire primary packaging has not been sent for evaluation.No defect or deviation was identified during the product evaluation.Without the entire packaging, no conclusion can be done regarding the sealing integrity.The complaint can not be confirmed.

• Brand Name: GYNECARE TVT EXACT CONTINENCE SYSTEM
• 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: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6249303
• MDR Text Key: 64768272
• Report Number: 2210968-2017-00209
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132054
• 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,Followup
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: TVTRL
• Device Lot Number: 3886730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/30/2017; 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• 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