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 Adhesion(s) (1695); Pain (1994); Blood Loss (2597); Not Applicable (3189)

Event Date 04/20/2014

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 that the patient underwent sling procedure in (b)(6) 2014.It was reported that the patient would also undergo repair of vaginal prolapse, removal of ovaries.The patient was in the hospital for six days and struggled to recover once home.The patient experienced severe constipation and constant abdominal and groin and leg pain.Six weeks post-op, the patient experienced rectal bleed and was referred urgently to a colorectal surgeon.The patient was seen within a week and surgeon performed a flexible sigmoidoscopy which was negative.The patient underwent further investigation and had now slow bowel transition and the patient has bowel movement every ten to fifteen days and intussusception.The patient had surgery and the consultant could not access the bowel because mesh was obstructing it.The patient reported that the physician spent over two hours removing adhesions.The patient was referred to the specialist colorectal service and was seen in (b)(6) 2017.The patient is still waiting for colorectal surgery.Additional information has been requested.

Manufacturer Narrative

This medwatch report is being voided as it is a duplicate of (b)(4) (ethicon reference number).Please see (b)(4) for all information regarding this event.

• 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: 7286998
• MDR Text Key: 100611844
• Report Number: 2210968-2018-70960
• 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,Followup
• Report Date: 01/31/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 03/20/2018
• 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