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

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

Patient Problems Unspecified Infection (1930); Ambulation Difficulties (2544)

Event Date 09/24/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2021 and the mesh was implanted.It was reported that the patient experienced vaginal candida symptoms and limited movement of the left leg in some movements.It was also reported that patient was given drug therapy.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Component code: (b)(4) device not returned.If further details are received at a later date a supplemental medwatch will be sent.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/09/2021.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.Additional information: additional event details - end date: (b)(6) 2021.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.Date and name of initial surgical procedure the diagnosis and indication for the initial surgical procedure? other relevant patient history/concomitant medications product lot#.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? what medical intervention was performed for the limited leg movement and infection? results? what is physician¿s opinion as to the etiology of or contributing factors to the limited leg movement and infection? what is the patient's current status? product complaint # (b)(4).Date sent to the fda: 12/09/2021.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.Corrected information: g1 - manufacturer site postal code = (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 03/02/2021.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.Additional b5 narrative: it was reported that a patient underwent a sling procedure on (b)(6) 2021 and the mesh was implanted.It was reported that the patient experienced vaginal candida symptoms and limited movement of the left leg in some movements.It was also reported that patient was given drug therapy.It was also reported that the outcome was recovered/resolved without sequelae.Additional information was requested.

• Brand Name: TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 200 ; SZ 200
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12763727
• MDR Text Key: 280931456
• Report Number: 2210968-2021-10995
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 11/10/2021; 02/02/2022
• Supplement Dates FDA Received: 12/09/2021; 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female