MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

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

Patient Problems Erosion (1750); Fever (1858); Pain (1994); Rash (2033); Swelling (2091); Abdominal Distention (2601); 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 the later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a hernia repair on (b)(6) 2014 and the mesh was implanted.As reported, since the procedure, the patient experienced hi blood stomach aches and mild fevers continually.In the last two months, the patient developed skin rash filled with watery fluid.The pain increased in kidney area and now serious bloating and blocked bowel occurred.Currently, the patient will be seeking medical advice in (b)(6).It was also reported that the patient seems better now as bowel is working ok again, bloated stomach is relaxed, and kidneys are sore but not as much.Recently, the patient noticed that right testicle has increased in size to nearly double its normal size.The patient developed hydrocele rhs caused by leakage from the intestine into the inguinal channel.The patient experienced a mesh migration.The patient reported that he is not in pain just an altered feeling in that area.The patient will see a doctor on (b)(6) 2018.

Manufacturer Narrative

(b)(4).Date sent to the fda: 02/07/2019.Attempts were 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?.

Manufacturer Narrative

Date sent to fda: 2/22/2019.Additional narrative: it was reported that the patient underwent hernia repair surgery on (b)(6) 2014 and an unknown mesh was implanted into the patient.It is reported that the patient experienced mild fevers, skin rashes, pain, bloating, and mesh migration.

• Brand Name: VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
• 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: 8118634
• MDR Text Key: 128879741
• Report Number: 2210968-2018-77416
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K810428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention