J&J BAND AID BRAND FIRST AID FLEXIBLE GAUZE ROLLED 381371161416

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-14 for J&J BAND AID BRAND FIRST AID FLEXIBLE GAUZE ROLLED 381371161416 manufactured by Johnson & Johnson Consumer Inc.

MAUDE Entry Details

Report Number2214133-2019-00121
MDR Report Key9186145
Report SourceCONSUMER
Date Received2019-10-14
Date of Report2019-09-18
Date Mfgr Received2019-09-18
Device Manufacturer Date2019-05-22
Date Added to Maude2019-10-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactLAURIE RAUCO
Manufacturer Street199 GRANDVIEW RD
Manufacturer CitySKILLMAN NJ 085589418
Manufacturer CountryUS
Manufacturer Postal085589418
Manufacturer Phone2152734905
Manufacturer G1ALLMED MEDICAL PRODUCTS CO. LTD
Manufacturer StreetNO. 76 YOUYI ROAD ZHIJIANG CITY
Manufacturer CityHUBEI 443200
Manufacturer CountryCH
Manufacturer Postal Code443200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJ&J BAND AID BRAND FIRST AID FLEXIBLE GAUZE ROLLED
Generic NameGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE
Product CodeNAB
Date Received2019-10-14
Model Number381371161416
Lot Number1319A
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON CONSUMER INC
Manufacturer Address199 GRANDVIEW RD SKILLMAN NJ 085589418 US 085589418


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-14

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