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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 Interaction Problem (4001)
Patient Problems Edema (1820); Seroma (2069); Swelling (2091); Reaction (2414)
Event Date 05/31/2020
Event Type  Injury  
Manufacturer Narrative
As reported, post implant of perfix plug the incision had mild redness, swelling and a small amount of fluid. Based on the information provided, no conclusion can be made as to the degree to which the bard device, may have caused or contributed to the patient¿s reported symptoms. The instructions for use supplied with this device lists seroma as a possible complication. Review of manufacturing records indicate product was manufactured to specification. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in december, 2018. Should additional information be provided, a supplemental mdr will be submitted. Not returned - remains implanted.
 
Event Description
As reported, the patient underwent right-sided inguinal plug tension-free hernia repair on (b)(6) 2020 and a bard/davol perfix plug was implanted. Four days after the operation on (b)(6) 2020, the incision had mild redness, swelling and a small amount of fluid. Considering the local reaction caused by the hernia ring filler, anti-infection treatment was provided, local dressing was changed, and the wound healed well.
 
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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 Key11097630
MDR Text Key224513876
Report Number1213643-2020-20089
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
Type of Report Initial
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0112780
Device Lot NumberHUCX2968
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2018
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: 12/30/2020 Patient Sequence Number: 1
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