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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 7148
Device Problem Incomplete or Missing Packaging (2312)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2018
Event Type  malfunction  
Manufacturer Narrative
Submit date: 5-21-2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reported client states gauze x-rad had only 9.
 
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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 Key7529824
MDR Text Key108858141
Report Number1018120-2018-00060
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 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7148
Device Catalogue Number7148
Device Lot Number17M046262
Was Device Available for Evaluation? No
Date Manufacturer Received05/18/2018
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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