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

Catalog Number ULTRAHSUNK

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Itching Sensation (1943); Pain (1994); Hernia (2240); Hypoesthesia (2352); Not Applicable (3189)

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 study to examine the improvement in pain and quality of life, and the economic impact of unilateral open mesh repair.The patient underwent an open mesh repair of a primary unilateral inguinal hernia on an unknown date and mesh was implanted.At 12 months after surgery, it was reported that the patient may have experienced a greater number or severity of symptoms (such as pain, numbness, itching).Three to four years after the procedure, the patient is still experiencing pain, reported as a shooting pain in the incision area.Symptoms did not affect their physical abilities and none used analgesics.The patient may have undergone further surgery for recurrent hernia and were asymptomatic thereafter.No additional information was reported.

Manufacturer Narrative

Date sent to fda: 9/3/2019.

• 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.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6944330
• MDR Text Key: 89262961
• Report Number: 2210968-2017-70490
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULTRAHSUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1