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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 7317 SPG VISTEC 4X4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

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COVIDIEN 7317 SPG VISTEC 4X4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE Back to Search Results
Model Number 7317
Device Problem Material Separation (1562)
Patient Problem No Patient Involvement (2645)
Event Date 04/16/2019
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
Customer reports that the radiopaque blue strip is not staying in tact to the sponge and falling apart.They opened a few different packages and the issue varies from each package with some being minor to others being unusable.The packages that were opened were not used on a patient.They were removed beforehand.
 
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Brand Name
7317 SPG VISTEC 4X4 STR 10'S
Type of Device
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Manufacturer (Section D)
COVIDIEN
1430 marvin griffin road, po b
augusta GA 30906
Manufacturer (Section G)
COVIDIEN
1430 marvin griffin road, po b
augusta GA 30906
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key8544938
MDR Text Key142931058
Report Number1018120-2019-00356
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,user f
Reporter Occupation Other
Type of Report Initial
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number7317
Device Catalogue Number7317
Device Lot Number18J019862
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/16/2019
Initial Date FDA Received04/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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