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

Catalog Number TVTS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Pain (1994); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).In addition, a 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.(b)(4).Total number of events ¿ 8.Tension free vaginal tape ¿ secur - 8.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2009 concurrently with cystoscopy and the mesh was implanted.Following the procedure, the patient experienced pain, urinary problems, recurrence, infection, and bleeding.No further information is available.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2017 through (b)(4) 2017.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2017 through (b)(6) 2017 supplemental 01 - attachment: [(b)(6) 2017 pah supplemental 01.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2017 through november 30, 2017.

Manufacturer Narrative

Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2017 through (b)(4) 2017.

Manufacturer Narrative

Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2017 through november 30, 2017.

Manufacturer Narrative

Date sent to fda: 2/11/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2017 through november 30, 2017.

Manufacturer Narrative

Date sent to fda: 4/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2017 through november 30, 2017.

• Brand Name: TENSION FREE VAGINAL TAPE - SECUR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7114614
• MDR Text Key: 94755369
• Report Number: 2210968-2017-71767
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Catalogue Number: TVTS
• Device Lot Number: 3308710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2019
• Date Device Manufactured: 06/08/2009
• 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
• Patient Age: 75 YR