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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 Erythema (1840); Unspecified Infection (1930); Swelling/ Edema (4577)
Event Date 05/10/2021
Event Type  Injury  
Manufacturer Narrative
As reported, 4 days post implant of the bard/davol perfix plug, the patient experienced redness, swelling, pain and a "mass"; was treated with anti-infection medications and recovered. Based on the information provided, no conclusion can be made. Review of manufacturing records confirms 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 (b)(4) units released for distribution in september, 2020. In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " should additional information be provided a supplemental mdr will be submitted. Not returned - remains implanted.
 
Event Description
Per nmpa ((b)(6) fda): as reported, the patient underwent left indirect inguinal hernia repair under aseptic conditions with implant of a bard/davol perfix plug on (b)(6) 2021. It was reported that the patient experienced post-operative complications including local redness, swelling, pain and "mass" on (b)(6) 2021. As reported, the patient was treated with anti-infection medications, local hot compress and the patient recovered on (b)(6) 2021.
 
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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 Key12289226
MDR Text Key265437048
Report Number1213643-2021-20238
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 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0112780
Device Lot NumberHUEV1632
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2020
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: 08/06/2021 Patient Sequence Number: 1
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