ABDOMINAL BINDER * A131067

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-25 for ABDOMINAL BINDER * A131067 manufactured by Deroyal Industries, Inc.

MAUDE Entry Details

Report Number3786031
MDR Report Key3786031
Date Received2014-04-25
Date of Report2014-04-25
Date of Event2014-04-10
Report Date2014-04-25
Date Reported to FDA2014-04-25
Date Reported to Mfgr2014-05-02
Date Added to Maude2014-05-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameABDOMINAL BINDER
Generic NameBINDER, ABDOMINAL
Product CodeFSD
Date Received2014-04-25
Model Number*
Catalog NumberA131067
Lot Number33405670
ID Number*
Device AvailabilityY
Device Age1 DA
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL INDUSTRIES, INC
Manufacturer Address200 DEBUSK LANE POWELL TN 37849 US 37849


Patients

Patient NumberTreatmentOutcomeDate
10 2014-04-25

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