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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, a foreign material was found on the perfix plug just after implant. The subject device was returned for evaluation. Visual evaluation of the sample finds that there is no foreign material other than blood / body fluid contamination present on the plug. The foreign material that was alleged to have been removed from the body was not returned with the perfix plug. Evaluation of the sample cannot determine how or when the alleged foreign material presented; as such a definitive root cause of the reported event could not be determined. 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 complaint reported for this manufacturing lot of (b)(4) units released for distribution in november, 2019. Should additional information be provided, a supplemental mdr will be submitted.
 
Event Description
As reported, during an open inguinal hernia procedure on (b)(6) 2021, a bard/davol perfix plug was implanted into the patient's body. After implant, a foreign material was found on the perfix plug. The foreign material was removed along with perfix plug. The procedure was completed using another perfix plug. As reported, the patient is doing well after the operation and there was no reported patient injury.
 
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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 Key12318675
MDR Text Key266406606
Report Number1213643-2021-20249
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0112780
Device Lot NumberHUDW0363
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2019
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: 08/13/2021 Patient Sequence Number: 1
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