MAUDE Adverse Event Report: ETHICON INC. MERSILENE TAPE UNKNOWN PRODUCT; INSTRUMENT, SURGICAL, DISPOSABLE

Device Problem Migration (4003)

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Urinary Tract Infection (2120); Not Applicable (3189)

Event Date 01/04/2019

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.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.The patient demographic info: weight, bmi at the time of the index procedure, date of the index surgical procedure in 2008.Is there a specific reason that the tape was left in situ after 2008 procedure? how was mersilene tape confirmed to be found in the bladder? what were the current symptoms following the index surgical procedure? onset date? what is the date of planned surgical intervention to remove the tape? other relevant patient history/concomitant medications.Product code and lot number? if applicable, will the product be returned, return date, tracking information? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.

Event Description

It was reported that the patient underwent insertion of suture for cervical incompetence to prevent miscarriage in 2008.It was reported that the suture is usually inserted in second trimester of pregnancy and removed at delivery.The suture was inserted in 2008 as a shirodkar suture during the patient¿s second pregnancy and could not be removed at the time of the patient¿s caesarean section in 2008.The patient then had another pregnancy and caesarean section and the suture was left in situ.Suture was seen in the patient¿s bladder on cystoscopy while investigating calcification in bladder, bladder pain and recurrent uti¿s.The suture will be excised from the patient¿s bladder by urology team as a joint procedure.Additional information has been requested.

• Brand Name: MERSILENE TAPE UNKNOWN PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8695651
• MDR Text Key: 147887528
• Report Number: 2210968-2019-82703
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• 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?: Yes
• Date Manufacturer Received: 05/16/2019
• 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
• Patient Age: 42 YR