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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUG; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUG; SURGICAL MESH Back to Search Results
Catalog Number 0112770
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
The sample was returned for evaluation and found the tyvek lid to be almost completely peeled back, off of the blister tray.As reported the customer claims this is an out of box condition.The perfix plug and onlay mesh remain in the blister tray.The sample evaluation confirms that a complete seal was in place and the tyvek lid sealed to the tray.There are no anomalies with the seal transfer as seen on the blister tray, a complete seal was in place.Examination indicates that the lid had been manually peeled back from the blister tray.The condition of the returned sample is consistent with that of packaging that has been manually opened.When the packaging was opened, cannot be determined.There is no damage to the blister tray or tyvek lid that would have contributed to the lid peeling back half way or having been almost completely peeled back as received.Based on the sample condition it cannot be determined when the product blister tray/ tyvek lid was opened.No manufacturing anomalies were identified.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in june, 2019.
 
Event Description
It was reported by a customer that on (b)(6) 2019 a bard perfix plug undamaged carton opened and the sterile package inside was reporter to have "half of the inner package not sealed." as reported there was no patient involvement.Sample was retuned for evaluation.
 
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Brand Name
PERFIX PLUG
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
laura sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key9516327
MDR Text Key193305847
Report Number1213643-2019-12496
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741016615
UDI-Public(01)00801741016615
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0112770
Device Lot NumberHUDR2320
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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