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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERFIX LIGHT PLUG; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. PERFIX LIGHT PLUG; SURGICAL MESH Back to Search Results
Catalog Number 0117080
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 05/09/2019
Event Type  malfunction  
Manufacturer Narrative
At this time no conclusion can be made.As reported the sample is available for return, however at this time has not been received.Without a sample to evaluate, we are unable to review the product in question for the alleged particle inside of the product packaging.To date this is the only reported complaint for this manufacturing lot released for distribution in 01/2019.Should the sample be received, a supplemental emdr will be submitted to document the results of the sample evaluation.Not returned.
 
Event Description
It was reported that a piece of small particle was allegedly seen in sterile packaging of a bard/davol perfix light plug.The product was not opened or used.
 
Manufacturer Narrative
At this time no conclusion can be made.As reported the sample is available for return, however at this time has not been received.Without a sample to evaluate, we are unable to review the product in question for the alleged particle inside of the product packaging.To date this is the only reported complaint for this manufacturing lot released for distribution in 01/2019.Should the sample be received, a supplemental emdr will be submitted to document the results of the sample evaluation.This is an addendum to the initial emdr to document the receipt and evaluation of the sample.The sample was returned unopened.Through visual evaluation a small fiber was identified in the sealed blister tray.As the blister tray was returned sealed this would suggest that the fiber was present during the inner packaging and sealing process and was not detected during visual inspections performed.This complaint is confirmed for having a manufacturing related root cause.To date this is the only reported complaint for this production lot of 271 units released for distribution in january, 2019.
 
Event Description
It was reported that a piece of small particle was allegedly seen in sterile packaging of a bard/davol perfix light plug.The product was not opened or used.
 
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Brand Name
PERFIX LIGHT PLUG
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key8663217
MDR Text Key146818611
Report Number1213643-2019-04545
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741030970
UDI-Public(01)00801741030970
Combination Product (y/n)N
PMA/PMN Number
K092032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/28/2023
Device Catalogue Number0117080
Device Lot NumberHUCZ0130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Date Manufacturer Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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