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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 LIGHT SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117080
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Discomfort (2330)
Event Date 10/09/2021
Event Type  Injury  
Manufacturer Narrative
As reported post-implant of the bard/davol perfix plug light, the patient experienced foreign body sensation. It was reported that the patient continues postoperative anti-inflammatory treatment. Additional information has been requested. Based on the available information, no conclusion can be made. No lot number was provided; therefore, a review of the manufacturing records is not possible.
 
Event Description
As per nmpa ((b)(4)): as reported, the patient was hospitalized for a right groin oblique and was implanted with a bard/davol perfix light plug on (b)(6) 2021. It was reported that on (b)(6) 2021, the patient was experienced foreign body sensation at the implantation site but the surrounding soft tissues had no redness, swelling and pain, the dressing outside the incision was dry, and there was no bleeding or exudation. It was also reported the patient continues postoperative anti-inflammatory treatment.
 
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Brand NamePERFIX PLUG LIGHT
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 Key13124787
MDR Text Key283300836
Report Number1213643-2021-20494
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K092032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0117080
Was Device Available for Evaluation? No
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/31/2021 Patient Sequence Number: 1
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