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

Catalog Number TVTRETUNK

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

Patient Problems Calcium Deposits/Calcification (1758); Urinary Tract Infection (2120); Hematuria (2558); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: it was unable to obtain any further information.The patient demographic info: age, weight, bmi at the time of index procedure.Were there any complications during the procedure? were any abnormalities noted prior, during, or after the initial procedure? was any anomaly of the device identified? when was the mesh perforation with large stone formation found? please provide date and details/findings of mesh removal and bladder repair? what is in surgeon¿s opinion a cause of mesh perforation at the bladder neck? other relevant patient history/concomitant medications product code and lot #.Will product be returned? if yes, please provide a return date, tracking information? what is the patient's current status after surgical intervention?.

Event Description

It was reported that the patient underwent a sling/urogynecological procedure in 2007 and the mesh was implanted.It was also reported that the patient presented with severe lower urinary tract symptom's and urinary tract infections/hematuria.Cystoscopy was performed.Mesh perforation at bladder neck with large stone formation extending into bladder was found.The patient will require medium/ major level surgery to remove mesh tape and repair bladder.No further information is available.

• Brand Name: TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 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, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8567653
• MDR Text Key: 143676346
• Report Number: 2210968-2019-80855
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TVTRETUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• 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