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

Catalog Number	0117170
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); Injury (2348); Disability (2371)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol perfix light plug (device #2) used to treat the patient.Should additional information be provided a supplemental emdr will be submitted.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.This emdr represents the bard/davol perfix light plug (device #2).An additional emdr was submitted to represent the bard/davol perfix plug (device #1) and bard/davol perfix light plug (device #3).Not returned.
Event or Problem Description
It is alleged by patient's attorney that on or about (b)(6) 2008, patient underwent surgery for a repair of a left inguinal hernia.As alleged a bard/davol perfix plug (device #1), was implanted to repair the hernia defect.It is alleged by the patient's attorney that on or about (b)(6) 2010, patient underwent surgery for a repair of a right inguinal hernia.As alleged, a bard/davol perfix light plug (device #2), was implanted to repair the hernia defect.It is also alleged by the patient's attorney that on or about (b)(6) 2011, patient underwent surgery for a repair of an umbilical hernia.As alleged, a bard/davol perfix light plug (device #3), (note: lot number not valid for reference number) was implanted to repair the hernia defect.It is alleged by the patient's attorney that on or about (b)(6) 2018, patient underwent an additional surgery to remove the perfix light plug (device #3) that was previously implanted on (b)(6) 2011 and again repair the ventral hernia defect.As alleged, patient has suffered and continues to suffer from chronic pain, as well as psychological stress and depression.As reported, patient has undergone and will likely require in the further other forms of care and medical treatments due to the alleged defective perfix plug.

• 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: 9363748
• Report Number: 1213643-2019-11441
• Device Sequence Number: 3231938
• Product Code: FTL
• UDI-Device Identifier: 00801741031007
• UDI-Public: (01)00801741031007
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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: 07/28/2012
• Device Catalogue Number: 0117170
• Device Lot Number: HUUG1382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/22/2019
• 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