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

Catalog Number UNKAA053

Device Problems Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Injury (2348); Disability (2371); Insufficient Information (4580)

Event Date 07/29/2020

Event Type  Death  

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that the patient underwent surgery for the implant of an unspecified bard/davol perfix plug on (b)(6) 2009.As reported, the patient is making a claim for an adverse patient outcome against the perfix plug.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.

Event Description

Attorney alleges that the patient underwent surgery for the implant of an unspecified bard/davol perfix plug on (b)(6) 2009.As reported, the patient is making a claim for an adverse patient outcome against the perfix plug.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per amended legal claim: attorney alleges that the patient underwent surgery for implant of unspecified bard/davol perfix plug on (b)(6) 2009.As reported, the patient is making a claim for an adverse patient outcome against perfix plug.Attorney alleges wrongful death of the patient.Attorney alleges that on (b)(6) 2020, the patient passed away due to, "defendants¿ negligence, defective product, defective design, failure to warn, and/or other wrongful act(s)".It is alleged that "the failed bard mesh device that was implanted in the patient was a substantial cause in the death".As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the plaintiff." it is also alleged that the plaintiff experienced emotional distress and the device was defective.

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this is an addendum to the initial emdr submitted (mdr number 1213643-2019-12583).This supplemental emdr is being submitted to report the allegation of patient death.No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including death and "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the plaintiff".No medical records, autopsy report, or death certificate have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned.

• Brand Name: PERFIX PLUG
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 9532594
• MDR Text Key: 174312475
• Report Number: 1213643-2019-12583
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA053
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Death
• Patient Sex: Male