• 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. -1213643 BARD SOFT MESH 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. -1213643 BARD SOFT MESH SURGICAL MESH Back to Search Results
Catalog Number 0117011
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Reaction (2414); Obstruction/Occlusion (2422); Ambulation Difficulties (2544)
Event Date 03/20/2020
Event Type  Injury  
Manufacturer Narrative

As reported, it was alleged that the patient experienced bowel obstruction, inflammation, joint pain, ambulation difficulties and surgical intervention post implant of the bard soft mesh. Based on the information provided to date, no conclusion can be made as to the degree to which the bard device, may be causing or contributing the patient¿s reported symptoms. The instructions-for-use supplied with the device lists inflammation and pain as possible complications. A review of the manufacturing records was performed and found that the lot was manufactured to specification. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in october, 2018. Should additional information be provided, a supplemental mdr will be submitted. Remains implanted.

 
Event Description

The following was reported to bdi/davol: on (b)(6) 2020: a (b)(6)-year old male patient underwent ventral umbilical hernia repair procedure with implant of a bard/davol soft mesh. On (b)(6) 2020: the patient returned to the hospital due to a bowel obstruction and underwent additional surgical intervention. Although there was no hernia recurrence, a non-bard/davol resorbable mesh was placed on top of the previously placed bard/davol soft mesh for reinforcement of the repair and to relieve the bowel obstruction. Following the surgeries with implant of both meshes, the patient has experienced joint pain, starting at the ankles and eventually radiating to the upper extremities, inflammation, nausea, extreme fatigue, erythema at the hernia repair site, itching and ambulation difficulties. The patient was treated with two rounds of prednisone and is currently on allopurinol which was prescribed by the rheumatologist. The patient underwent multiple tests, which showed no hernia recurrence or fluid accumulations. It was reported that the patient has not had relief of the symptoms with the treatment received, can "barely walk" and is seeking treatment with a specialist.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD SOFT MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
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
8005566756
MDR Report Key10809304
MDR Text Key215306502
Report Number1213643-2020-20036
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 10/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0117011
Device LOT NumberHUCW1490
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/24/2018
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: 11/09/2020 Patient Sequence Number: 1
-
-