MAUDE Adverse Event Report: ETHICON INC. ETHICON MESH UNKNOWN; MESH, SURGICAL, POLYMERIC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Hernia (2240); Blood Loss (2597); No Code Available (3191)

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 a hernia repair procedure in 1992 and mesh was implanted.The patient reported that she is unable to defecate which requires daily enemas.The patient reported that when they are able to go, there is blood.The patient reported that they now have a heart infection, shredded colon and shredded intestines.No additional information has been provided.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.Additional information was requested, and the following was obtained: the patient mentioned that she is also diabetic now and her heart is reportedly not strong enough to have another surgery, she has had a heart infection caused by it.She has been told that being a diabetic is being caused by her nerves.She can go at times three weeks without having a bowel movement.The doctor wanted to do the surgery, but the anesthesiologist doesn¿t want to due to the heart infection, afraid she¿ll have a heart attack on the table.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 attached.

Manufacturer Narrative

Pc-(b)(4).Patient codes: (b)(4).The mesh was implanted on (b)(4) 1992 to repair hernia.The patient experienced problems with bowel movements at first week of surgery, unable to have a stool for about two weeks, had constipation and after two weeks, was severely bleeding with pain.The patient also experienced severe pain to the right area hip, high blood pressure, diabetes and depression.The patient has enemas and laxatives all the time.It was reported by the patient that the mesh has deteriorated and caused adhesions on large colon.The patient had ultrasound on (b)(4) 2016, colonoscopy on (b)(4) 2017, ekg and cat scan.The patient reported that she is unable to have another hernia surgery because of heart condition.The patient is taking loritabs 7.5, correctol, gas-x, laxatives, ibuprofen 500mg, smz/tmp ds tab 800mg, sucralfate tab 1g and amlodipine tab 5mg.It was reported that on (b)(4) 2016, the patient was in the emergency room for abdominal and epigastric pain, hypocalcemia, uti, high blood sugar and gerd.Protonix, carafate and keflex were prescribed and follow-up scheduled for pending urine culture and further testing in 2-3 days.On (b)(4) 2017, the patient underwent a colonoscopy for intermittent rectal bleeding and chronic constipation.External and internal hemorrhoids along with redundant colon were findings of colonoscopy.

Manufacturer Narrative

Pc-(b)(4).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.Please provide a name of initial surgical procedure in (b)(4) 1992 the diagnosis and indication for the initial surgical procedure? was the procedure associated with this event open or laparoscopic? if applicable in what tissue layer did you place the mesh? were any concomitant procedures performed? other relevant patient history/concomitant medications what were current symptoms following the index surgical procedure? onset date? has the hernia been recurred? if yes: - how much time from initial hernia repair to hernia recurrence? - was there any triggering event prior to present recurrence? - how was the recurrence diagnosed? if reoperation was performed, please provide surgical findings: - please provide the date of reoperation - mesh location and integrity - was any deficiency or anomaly of the mesh? if yes, please describe it.- are there any pictures available? was the device removed? if so, please date and details of the re-operation.What medical intervention was performed? results? what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current condition?.

• Brand Name: ETHICON MESH UNKNOWN
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7456686
• MDR Text Key: 106383301
• Report Number: 2210968-2018-72333
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• 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
• Date Manufacturer Received: 10/31/2018
• 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 Age: 54 YR
• Patient Weight: 73