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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG SURGICAL MESH Back to Search Results
Catalog Number 0112780
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Impaired Healing (2378); Fluid Discharge (2686)
Event Date 05/17/2021
Event Type  Injury  
Manufacturer Narrative
As reported, the patient experienced fluid discharge, impaired wound healing and underwent removal of the bard/davol perfix plug. Additional information has been requested. Based on the information provided to date, no conclusion can be made. Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported. To date, this is the only reported complaint for this manufacturing lot of 252 units released for distribution in (b)(6) 2020. Should additional information be provided, a supplemental mdr will be submitted.
 
Event Description
As per nmpa (b)(6): on (b)(6) 2021 the patient underwent left side refractory indirect inguinal hernia plug tension-free repair with implant of a bard/davol perfix plug under spinal anesthesia. On (b)(6) 2021 exudation from the incision occurred eight days after the operation, the patient visited the outpatient department and was given additional dressing. As reported, the exudation continued to increase, which was considered to be caused by hernia rejection. On (b)(6) 2021 the patient was re-admitted to the hospital as the incision healed poorly. On (b)(6) 2021 the patient underwent left indirect inguinal hernia plug removal under combined spinal epidural anesthesia.
 
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Brand NamePERFIX PLUG
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 Key12048280
MDR Text Key257704293
Report Number1213643-2021-20154
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0112780
Device Lot NumberHUES0214
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2020
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: 06/23/2021 Patient Sequence Number: 1
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