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

Catalog Number	0117080
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); Deformity/ Disfigurement (2360); Disability (2371)
Date of Event	05/02/2013
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 may have caused or contributed to the reported event.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2010: the patient underwent a laparoscopic incisional hernia repair.A bard/davol perfix light plug was implanted in the patient during this repair.(b)(6) 2013: the patient underwent repair of recurrent l indirect inguinal hernia.The surgeon noted a large piece of mesh from previous repair was so adherent in the tissues it could not be removed.The patient continues to suffer complications, permanent disfigurement and chronic pain.The mesh implanted in the patient failed to reasonably perform as intended.The mesh caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the mesh was initially implanted to treat.The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, and impairment.

• 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: 8282643
• Report Number: 1213643-2019-00504
• Device Sequence Number: 13494692
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2019

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: 01/28/2012
• Device Catalogue Number: 0117080
• Device Lot Number: HUTL1604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/28/2019
• 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