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

Catalog Number	0117180
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Injury (2348); Disability (2371)
Date of Event	11/13/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hematoma, pain and surgical intervention; however, no details have been provided.The instructions-for-use supplied with the device lists hematoma and pain as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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 be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that on or about (b)(6) 2014, the patient underwent a surgery for the repair of left inguinal hernia and two bard/davol perfix light plugs were implanted to repair the hernia defect.It is alleged that on or about (b)(6) 2014, the patient underwent an additional surgery for excision of a chronic hematoma in the left groin with a primary repair of an inguinal hernia.It is alleged that the patient was injured severely and permanently.The patient suffered pain, disability, hospitalizations and additional surgeries.It is also alleged that the patient has suffered and will continue to suffer physical pain, chronic pain, mental anguish, psychological stress, depression, has undergone and will likely require medical treatments and other forms of care.Attorney also alleges that the device was defective.

• Brand Name: PERFIX PLUG LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10705459
• Report Number: 1213643-2020-09506
• Device Sequence Number: 16925343
• Product Code: FTL
• UDI-Device Identifier: 00801741031014
• UDI-Public: (01)00801741031014
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

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: 03/28/2019
• Device Catalogue Number: 0117180
• Device Lot Number: HUYC0636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/20/2020
• 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; Disability