MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERFIX LIGHT PLUG; SURGICAL MESH

Catalog Number	0117060
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Vomiting (2144); Hernia (2240)
Date of Event	06/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provide at this time, no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the alleged patient postoperative symptoms.This event was reported via maude event report and did not include contact information.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Recurrence and pain are listed in the adverse reaction section of the instructions-for-use as possible complications.Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.
Event or Problem Description
Per fda report mw5085555 - "my son had gotten a right inguinal hernia and sent in for operation on (b)(6) 2016.He had a mesh perfix light plug- mfr: davol, a div.Of bard, model 0117060, lot # huap0309.My son was in so much pain after surgery, what was supposed to be same day surgery ended up being 5 days in hospital.The pain started a day after he got the mesh put in.My son swore that the hernia was not fixed.He was still in major pain.A few months later, i took him back to emergency room because of pain and the drs said he had a hernia again but it was too small to repair.My son has constant pain in his groin.He also has radiating pain which is in his belly button across one side by his kidney into his back area.I have taken him to emergency room two more times since the last and drs keep saying they cannot see the issue and why he has pain.They had seen that the hernia was there but no steps have been taken to repair or check the status of the mesh that was placed in him during his operation for the inguinal hernia.My son has good and bad days.But when the pain starts up, my son is in so much pain that it is unbearable.There is tenderness and swelling in the area.He has thrown up and felt nauseous due to the pain.I believe this is due to the mesh implant.My son is only (b6).He was in perfect health before he received the mesh implant in 2016.Due to pain it is also causing him to get chest pain, and go into panic attacks because he is worrying that something is wrong due to the amount of pain he is in.".

• Brand Name: PERFIX LIGHT PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8583688
• Report Number: 1213643-2019-03624
• Device Sequence Number: 2220347
• Product Code: FTL
• UDI-Device Identifier: 00801741030956
• UDI-Public: (01)00801741030956
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 0117060
• Device Lot Number: HUAP0309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention