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

Catalog Number 0112760

Device Problem Material Disintegration (1177)

Patient Problems Abscess (1690); Fever (1858); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

Multiple attempts have been made to contact the patient and obtain additional information.To date the patient has not responded to any of our requests.At this time, no conclusion can be made as to the degree to which the mesh implant may be causing or contributing to the reported patient outcome.Should additional information be provided, a supplemental mdr will be submitted.A review of the manufacturing records was performed and found that the lot was manufactured to specification, with no anomalies noted.To date there have been no other reported complaints for this lot of (b)(4) units released for distribution on 10/17/2008.The information provided by bard 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 bard.Device remains implanted.

Event Description

As reported the patient has a bard perfix plug device implanted.She reports that she has been feverish for 3-4 years.As reported she went to her doctor and he told her that "either the mesh is breaking up and her body is rejecting it or she has sugar diabetes." she reports that she now has an abscess that is draining and cannot take antibiotics because she is allergic to all of them.

• 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: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6489330
• MDR Text Key: 72658297
• Report Number: 1213643-2017-00240
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(10)HUSI2037
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Catalogue Number: 0112760
• Device Lot Number: HUSI2037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2008
• 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): Required Intervention