JOHNSON & JOHNSON BAND-AID? BRAND OF FIRST AID PRODUCTS SECURE-FLEX? WRAP 381371161508

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 2018-06-26 for JOHNSON & JOHNSON BAND-AID? BRAND OF FIRST AID PRODUCTS SECURE-FLEX? WRAP 381371161508 manufactured by Johnson & Johnson Consumer Inc.

Event Text Entries

[112870719] (b)(4). Lot number = unknown. Device is not expected to be returned for manufacturer review/investigation. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. (b)(4) - part of recall number z-1203-2018. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[112870720] Consumer reported some itching and red bumps after using johnson and johnson band-aid secure flexcare wrap. Consumer, started using them (b)(6) 2017 and is still using them. Additionally, to treat the itching and bumps consumer used hydrocortisone cream and put the wrap over a sock. Consumer is using it for pain caused by erythema and small vesicles and does consider himself recovered.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2214133-2018-00014
MDR Report Key7638709
Report SourceCONSUMER
Date Received2018-06-26
Date of Report2018-01-04
Date Mfgr Received2018-01-04
Date Added to Maude2018-06-26
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 ContactLINDA PLEWS
Manufacturer Street199 GRANDVIEW RD
Manufacturer CitySKILLMAN NJ 085589418
Manufacturer CountryUS
Manufacturer Postal085589418
Manufacturer Phone2152737120
Manufacturer G1CAREMAX
Manufacturer StreetNO. 43, SHUANG JING STREET FENG TING RD
Manufacturer CitySIP, JIANGSU, P.R. 215121
Manufacturer CountryCH
Manufacturer Postal Code215121
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ1203-2018
Event Type3
Type of Report3

Device Details

Brand NameJOHNSON & JOHNSON BAND-AID? BRAND OF FIRST AID PRODUCTS SECURE-FLEX? WRAP
Generic NameBANDAGE, ELASTIC
Product CodeFQM
Date Received2018-06-26
Model Number381371161508
ID Number(01)381371161508
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON CONSUMER INC
Manufacturer Address199 GRANDVIEW ROAD SKILLMAN NJ 085589418 US 085589418


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-26

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