MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBTURATOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number 810081

Device Problems Material Integrity Problem (2978); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).  a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.    additional information was requested and the following was obtained: please clarify was sterility of the product affected? unk.Status of product return.Noted.  photo(s) of the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Evaluation: the received device was manipulated as the box was opened and the labels were not present.The blister was deformed, however the lid was still well sealed.Traceability labels were present on the blister.Inside it, many blue mesh particles were present and the white needle tips were damaged (cause by deformation of blister).The defect identified is not linked to a manufacturing issue.No further investigation will be conducted on this complaint due to external cause.Complaint information will be included in complaint trending that is reviewed by the applicable product quality and safety surveillance data review board on a regular basis to determine if further action is necessary.The potential cause is related to an external cause (overheating during storage or re sterilization): the product was conforming to specifications at the release.The manufacturing process could not create this defect.The product must be stored at maximum 25°c and should not be re sterilized twice.

Event Description

It was reported that a patient underwent an unknown surgery on (b)(6) 2021 and the mesh was used.Prior to surgery, the needle and package for the device was found deformed in the newly dispensed needle when preparing for surgery.Upon evaluation of the returned device the blister was found deformed, however the lid was still well sealed.Inside it, and the white needle tips were damaged.A like device was used to complete the surgery.There was no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 07/29/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 3936483 and product code 810081.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 08/26/2021.Additional h3 evaluation: pictures and video were returned for analysis.Upon visual inspection of the picture, the deformed packaging and damaged white needle tips could be observed (cause by deformation of blister).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: GYNECARE TVT OBTURATOR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12105881
• MDR Text Key: 259628481
• Report Number: 2210968-2021-05985
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3936483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 07/04/2021; 07/30/2021
• Supplement Dates FDA Received: 07/29/2021; 08/26/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1