7317 SPG VISTEC 4X4 STR 10'S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2020-01-22 for 7317 SPG VISTEC 4X4 STR 10'S manufactured by Covidien.

Event Text Entries

[176033845] 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.
Patient Sequence No: 1, Text Type: N, H10


[176033846] The customer reported that the sponges were opened onto the surgical field and there were 15 sponges inside a package that are supposed to contain 10 sponges.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018120-2020-00401
MDR Report Key9619462
Report SourceCONSUMER,USER FACILITY
Date Received2020-01-22
Date of Report2020-01-22
Date of Event2020-01-20
Date Mfgr Received2020-01-20
Date Added to Maude2020-01-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer Street1430 MARVIN GRIFFIN ROAD, PO B
Manufacturer CityAUGUSTA GA 30906
Manufacturer CountryUS
Manufacturer Postal Code30906
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name7317 SPG VISTEC 4X4 STR 10'S
Generic NameGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Product CodeGDY
Date Received2020-01-22
Model Number7317
Catalog Number7317
Lot Number19J050962
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address1430 MARVIN GRIFFIN ROAD, PO B AUGUSTA GA 30906 US 30906


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-22

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