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

Catalog Number ETHMESHUNK

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Unspecified Infection (1930); Pain (1994); Renal Failure (2041); Hernia (2240); Peritonitis (2252)

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 an unknown procedure in 2014 or 2015 to stop the hernias and to stop feces from passing in urine and mesh was implanted.The patient has experienced severe pain, infection, peritonitis, unspecified hernias and chronic renal failure.The patient is unable to take pain medication due to the renal failure.The patient is also unable to eat or drink for unspecified reasons and is on a drip due to dehydration.The patient has also suffered from a heart attack which the patient believes is due to the extreme pain.No additional information is available.

• Brand Name: ETHICON MESH UNKNOWN
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 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 08876-0151 ; 9082182792
• MDR Report Key: 7068663
• MDR Text Key: 93281269
• Report Number: 2210968-2017-71486
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2017

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: ETHMESHUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/29/2017
• 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