MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO 10 X 15 CM, 3 / BOX; MESH, SURGICAL, POLYMERIC

Catalog Number UMN3

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Erosion (1750); Inflammation (1932); Pain (1994); Swelling (2091); Not Applicable (3189)

Event Date 12/21/2018

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.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? adverse event related to suture reported via mw # 2210968-2019-78796.

Event Description

It was reported by the patient that they underwent an unknown procedure on an unknown date.Following the procedure, the patient had surgery to partially remove mesh and suture.The patient reported they were having pain from mesh and suture.Additional information has been requested.

Manufacturer Narrative

This medwatch report is being voided as it is a duplicate of medwatch report 2210968-2019-78728.Please see medwatch report 2210968-2019-78728 for all information regarding this event.

Manufacturer Narrative

(b)(4).Patient codes: 1750, 1932, 1994, 2091, 3189- surgical intervention.Device codes: 4003.It was reported by the patient that they underwent an unknown procedure on an unknown date and mesh was implanted.The patient experienced chronic pain since implantation.The patient reported severe swelling and inflammation after one-week post-operative surgery.Eleven months after procedure, further surgery was required to trim out mesh, partially mesh removal.Additional information was requested.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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Patient questions: if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form.

Event Description

It was reported by the patient that they underwent an unknown procedure on an unknown date and mesh was implanted.The patient experienced chronic pain since implantation.The patient reported severe swelling and inflammation after one-week post-operative surgery.Eleven months after procedure, further surgery was required to trim out mesh, partially mesh removal.Additional information was requested.

Manufacturer Narrative

Patient codes: 1930, 1994, 2091, 3189- surgical intervention.Device codes: 2993.

Manufacturer Narrative

Additional information was requested, and the following was obtained: this is all the information i was given from the surgeon - she¿s had 2 operations in chesterfield and a lap hernia repair prior to me putting a small piece of ultro-pro in last year it was well incorporated when i looked last chronic symptoms and no cause seen the patient demographic info: age, weight, bmi at the time of index procedure date and name of index surgical procedure the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? onset date/time of the pain from surgery? please provide the date of reoperation and surgical findings.Was the device removed? other relevant patient history/concomitant medications lot number for the mesh umn3? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? is the suture ethicon product? if yes : -please provide a product code and lot number for the suture? - does the surgeon believe there was any alleged deficiency with the ethicon suture?.

• Brand Name: ULTRAPRO 10 X 15 CM, 3 / BOX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8323285
• MDR Text Key: 135677826
• Report Number: 2210968-2019-78797
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/18/2019

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
• Device Catalogue Number: UMN3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 02/19/2019; 02/18/2019; 03/26/2019; 03/26/2019
• Supplement Dates FDA Received: 02/21/2019; 02/22/2019; 03/26/2019; 03/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention