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

Catalog Number	0117060
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); Injury (2348); Disability (2371)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol perfix light plug (device #1) may have caused or contributed to the reported event.The attorney alleges recurrent hernia and surgery to remove the device.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.The cause of the patient postoperative complications cannot be determined at this time.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Information is limited.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol perfix light plug (device #1).An additional emdr was submitted to represent the bard/davol perfix plug (device #2).Not returned.
Event or Problem Description
It is alleged by the patient¿s attorney that the patient was a recipient of a bard /davol perfix light plug (device #1) (here in after ¿perfix light plug¿).It is alleged by the patient¿s attorney that on or about (b)(6) 2014, the patient underwent surgery for repair of massive inguinal hernia.As alleged, a bard/davol perfix light plug (device #1), was implanted to repair the hernia defect.It was alleged by the patient¿s attorney that on or about (b)(6) 2017, the patient underwent an additional surgery to remove the perfix light plug (device #1), again to repair the massive inguinal hernia, and to place a new perfix plug (device #2) in the patient.Allegedly, as a result, the patient was injured severely and permanently.As alleged, patient has suffered and will continue to suffer physical pain and mental anguish.As reported, patient suffered and from chronic pain, as well as psychological stress and depression due to the alleged defective perfix plug (device #2).

• 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: 8664303
• Report Number: 1213643-2019-04591
• Device Sequence Number: 11348033
• Product Code: FTL
• UDI-Device Identifier: 00801741030956
• UDI-Public: (01)00801741030956
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2019

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: 02/28/2019
• Device Catalogue Number: 0117060
• Device Lot Number: HUYB0940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/03/2019
• 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: Required Intervention; Disability