• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUG SURGICAL MESH Back to Search Results
Catalog Number 0112750
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Disability (2371); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the perfix plug may have caused or contributed to the patient's reported postoperative difficulties. As reported the patient is continuing to seek the advice of a medical professional to determine how to proceed medically. At this time no conclusions can be made. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be obtained, a supplemental emdr will be submitted. 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. Remains implanted.

 
Event Description

It was reported that on (b)(6) 2015 the patient underwent inguinal repair using the davol perfix plug. After the surgical postoperative appointment the contact reports the pain became worse. The patient was evaluated by multiple md's who performed nerve blocks and other injections which only provided temporary relief. The contact has reported that the patient is unable to find a surgeon who will perform a revision procedure. As reported the patient has been disabled as he has had ambulation difficulty and is unable to drive a vehicle due to his pain.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERFIX PLUG
Type of DeviceSURGICAL 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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7730803
MDR Text Key115351422
Report Number1213643-2018-02530
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 07/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/28/2019
Device Catalogue Number0112750
Device LOT NumberHUYI1494
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/24/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/30/2018 Patient Sequence Number: 1
-
-