MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG LIGHT; SURGICAL MESH

Catalog Number	0117070
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994)
Date of Event	12/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient alleged chronic pain, meshoma, internal bleeding and cutaneous femoral nerve post implant of perfix light plug.As reported no additional information will be forthcoming.Based on the information provided, no conclusion can be made as to the degree to which the device, may be causing or contributing the patients reported postoperative symptoms.The instructions-for-use supplied with the device lists pain as a possible complication.This is the only reported complaint to date for the reported lot number.This emdr represents the bard/davol perfix plug light (device #1).An additional emdr was submitted to represent the bard/davol perfix plug light (device #2).Should additional information, a supplemental mdr will be submitted.Not returned.
Event or Problem Description
The following was reported via tga report ((b)(6) fda): as reported the complaint cites the use of two perfix light plugs.The tga report states, "i went to see a surgeon regarding right hand side pain, i did a dye ct test and a small inguinal sac was found on the left.I went in to have the hernia repair done, i had 2 plugs put in and a large mesh on a genital femoral hernia that was not detected on dye ct scan.Patient outcome/consequences: cutaneous femoral nerve, meshoma, internal bleeding [redacted] was surprised i lasted as long as i did.After removing the mesh to the genital femoral area there was no hernia found.I have ongoing chronic pain which seen a neurostimulator was placed in my back.I have lost my dysfunctional in my sex life.Recently i have started coming down to with crps, i am due to have a ketamine infusion to lessen the pain.The mesh that was put in place did not need to be there, also this mesh has caused me chronic pain and now i am suffering crps.".

• Brand Name: PERFIX PLUG LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11148168
• Report Number: 1213643-2020-20097
• Device Sequence Number: 17045790
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

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: 07/28/2021
• Device Catalogue Number: 0117070
• Device Lot Number: HUAU0217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/11/2021
• 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: Required Intervention