MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 patient demographic info: age, weight and bmi at the time of index procedure date and name of initial surgical procedure? the diagnosis and indication for the initial surgical 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? were any concomitant procedures performed? onset date/time of the pain from surgery? location and character of the pain? was any medical or surgical intervention provided for the pain management? results? please provide the date of mesh removal and surgical findings.What is the patient's current status? 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent a sling procedure 16 years ago and mesh was implanted.The patient experienced pain and underwent mesh removal on an unknown date.The surgeon opined that a mistake was made in the initial procedure which led to the patient experiencing pain for 16 years.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to fda: 12/08/2020.Additional information: h6.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 inc, 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

(b)(4) date sent to fda: 10/26/2020.Additional information was requested and the following was obtained: date and name of initial surgical procedure? device had been implanted in 2004.Corrected b5 narrative: it was reported that a patient underwent a sling procedure in 2004 and mesh was implanted.The patient experienced pain and underwent mesh removal on an unknown date.The surgeon opined that a mistake was made in the initial procedure which led to the patient experiencing pain for 16 years.No further information is available.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 inc, 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.

Event Description

It was reported that a patient underwent a sling procedure in 2004 and mesh was implanted.The patient experienced pain and underwent mesh removal on an unknown date.The surgeon opined that a mistake was made in the initial procedure which led to the patient experiencing pain for 16 years.No further information is available.

Manufacturer Narrative

(b)(4).Date sent to fda: 02/22/2021.Additional information: d9.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 inc, 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

(b)(4).Date sent to fda: 03/02/2021.Additional information: h3, h6.H3 investigation summary: an explanted product of an unknown tvt device (unknown batch and product code) was received.The product was decontaminated and well packaged.The received device was manipulated and ex-planted as original packaging and all components were missing.Only the remaining part of the mesh was visible with lot of organic matter around.No batch manufacturing records was conducted, as product code and batch number were not available.The cause could not be established as the event description did not mention any specific defect.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 inc, 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: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10622947
• MDR Text Key: 209791080
• Report Number: 2210968-2020-07583
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/15/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/16/2020; 12/08/2020; 01/27/2021; 02/23/2021
• Supplement Dates FDA Received: 10/26/2020; 12/08/2020; 02/22/2021; 03/02/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention