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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 0112750
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 02/13/2020
Event Type  Injury  
Event Description
As reported, during an unspecified procedure on (b)(6) 2020, the patient was implanted with a bard/davol perfix plug. It was reported that post implant of the mesh, the patient experienced a burning sensation and pain in the groin area where the mesh was placed. As reported on (b)(6) 2022, a cat scan was performed to identify the causing factor of the pain.
 
Manufacturer Narrative
As reported, post-implant of the perfix plug, the patient experienced a burning sensation and pain. Patient has undergone a cat scan to identify the causing factor of the pain; the results have not been made unavailable at this time. Based on the information provided, no conclusion can be made. Review of manufacturing records confirms the product was manufactured to specification. To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in dec, 2018. Not returned - remains implanted.
 
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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 Key14279267
MDR Text Key290662326
Report Number1213643-2022-00200
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0112750
Device Lot NumberHUCX2280
Was Device Available for Evaluation? No
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2018
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: 05/04/2022 Patient Sequence Number: 1
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