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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN VISTEC; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
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COVIDIEN VISTEC; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE Back to Search Results
Model Number 7318
Device Problem Incomplete or Missing Packaging (2312)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
Submit date: 6-20-2018.The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reported tray only had 9 gauze sponges instead of 10.
 
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Brand Name
VISTEC
Type of Device
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Manufacturer (Section D)
COVIDIEN
1647 perkins rd
augusta GA 30913
Manufacturer (Section G)
COVIDIEN
1647 perkins rd
augusta GA 30913
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key7621106
MDR Text Key111743179
Report Number1018120-2018-00096
Device Sequence Number1
Product Code GDY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7318
Device Catalogue Number7318
Device Lot Number18B160462
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2018
Date Device Manufactured02/22/2018
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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