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

Catalog Number 0112960

Device Problems Expiration Date Error (2528); Defective Device (2588); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that on (b)(6) 2008, the patient underwent surgery for implant of an unspecified bard/davol perfix plug.As reported, the patient is making a claim for an adverse patient outcome against the perfix plug.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 patient.".

Event Description

Attorney alleges that on (b)(6) 2008, the patient underwent surgery for implant of an unspecified bard/davol perfix plug.As reported, the patient is making a claim for an adverse patient outcome against the perfix plug.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 patient." addendum: it was reported that the bard/davol perfix plug implanted in the patient in (b)(6), 2008 may have been expired and/or damaged and the patient had 3 new surgeries in the last 18 months to have it removed.

Manufacturer Narrative

At this time no conclusions can be made.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.This supplemental emdr was submitted to report the event and product identifiers provided.As reported, it is alleged that an expired mesh may have been implanted in 2008 and the patient underwent subsequent surgical intervention for removal.Review of manufacturing records indicate product was manufactured to specification and was valid until (b)(6), 2013.As such, the patient was not implanted with an expired mesh.Based on the information provided, no conclusion can be made as to the degree to which the bard perfix plug, may have caused or contributed to the patient¿s reported postoperative course.Corrected fields: d4 (product catalog no.), h11.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 - mesh explanted.

• 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
• MDR Report Key: 8516382
• MDR Text Key: 142035223
• Report Number: 1213643-2019-03033
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 0112960
• Device Lot Number: HUSA0780
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability