GABAUER'S PAIN EASE 386-0008-03

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-18 for GABAUER'S PAIN EASE 386-0008-03 manufactured by Gebauer Co.

Event Text Entries

[5773453] Gebauer's pain ease is a prescription topical anesthetic. The ingredients are not listed on the can. When i notified the company, they said the package insert is in the lid. Dose: spray, prn/as needed, topical.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5042517
MDR Report Key4752577
Date Received2015-03-18
Date of Report2015-03-18
Date Added to Maude2015-05-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameGABAUER'S PAIN EASE
Generic NameTOPICAL ANESTHETIC
Product CodeCCT
Date Received2015-03-18
Catalog Number386-0008-03
Lot Number6335
Device Expiration Date2016-10-01
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerGEBAUER CO


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-18

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