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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Pain (1994); Sweating (2444); Not Applicable (3189)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported by the patient that they underwent a gynecological procedure on (b)(6) 2016 and mesh was implanted.The patient reported that the device is causing pain inside vagina and does not know the reason why yet because it is being investigated.The patient has to have at least a partial removal and it has not improved incontinence and in some ways is worse.The patient reported they lose urine every time they stand up after urinating.The patient experiences intermittent sharp pains in groin and often feels as though the device may be falling out.The patient reported that they think it may have hardened instead of being the soft mesh they were told about.The patient reported there have been times when they had feces moving round and going across where the device is and patient has been doubled up and sweating because of the pain.The patient reported it has not improved their life and they have to be careful about all toilet needs.The patient just had surgery to make sure it has not eroded into bladder and it has not.The patient reported they feel like they have a solid object in there most of the time.The patient reported that when they told the surgeon at follow up, the patient was told to double vacate and try and have sex.No additional information was provided.

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7403573
• MDR Text Key: 104709763
• Report Number: 2210968-2018-71977
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2018

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
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/06/2018
• 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