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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 Purulent Discharge (1812); Impaired Healing (2378); Swelling/ Edema (4577)
Event Date 10/12/2021
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, no conclusion can be made. As reported, one month post implant of the perfix plug, the patient was re-admitted to the hospital with redness, swelling and pus on the surgical mouth. 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 july, 2019. Should additional information be provided a supplemental mdr will be submitted. Not returned - mesh explanted.
 
Event Description
As reported, the patient underwent tension-free inguinal hernia repair on (b)(6) 2021 and was implanted with a bard/davol perfix plug. After surgery, the wound healed well and the patient was discharged from the hospital on (b)(6) 2021. It was reported that on (b)(6) 2021, the patient was admitted to the hospital due to redness, swelling and pus on the surgical mouth. After debridement and dressing change, the incision was exuded and did not heal. It was reported that on (b)(6) 2021, the doctor decided to remove the implanted mesh and the mesh removal surgery was performed on (b)(6) 2021. Purulent fluid was noted in the implant. The wound healed well after the operation.
 
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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 Key12787452
MDR Text Key280586249
Report Number1213643-2021-20402
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 Other,Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0112780
Device Lot NumberHUDS2345
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2019
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: 11/10/2021 Patient Sequence Number: 1
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