RAYTEC SPONGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for RAYTEC SPONGE manufactured by Medline Industries, Inc.

Event Text Entries

[181770019] The raytec: sponge unraveled during the surgery while being used within the patient; fragments of the sponge had to be removed from the patient. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093392
MDR Report Key9774510
Date Received2020-02-28
Date of Report2020-02-26
Date of Event2020-01-30
Date Added to Maude2020-03-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAYTEC SPONGE
Generic NameGAUZE, SPONGE, INTERNAL X-RAY DETECTABLE
Product CodeGDY
Date Received2020-02-28
Lot Number19KBV286
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC
Manufacturer AddressNORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-28

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