OPSITE POST-OP9.5X8.5CM CN12 36361361

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for OPSITE POST-OP9.5X8.5CM CN12 36361361 manufactured by Smith & Nephew Medical Ltd..

Event Text Entries

[185914269] It was reported that the patient used the 3 opsite post-op dressings and none of them were waterproof, each time the patient used them in the shower they soaked up full of water and came off. Patient had to go out and buy more to cover the stitches.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8043484-2020-00243
MDR Report Key9903256
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-06
Date Mfgr Received2020-03-16
Date Added to Maude2020-03-31
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 ContactDR SARAH FREESTONE
Manufacturer Street101 HESSLE ROAD
Manufacturer CityHULL HU3 2BN
Manufacturer CountryUK
Manufacturer PostalHU3 2BN
Manufacturer Phone0447940038
Manufacturer G1SMITH & NEPHEW MEDICAL LTD.
Manufacturer Street101 HESSLE ROAD
Manufacturer CityHULL HU3 2BN
Manufacturer CountryUK
Manufacturer Postal CodeHU3 2BN
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPSITE POST-OP9.5X8.5CM CN12
Generic NameTAPE AND BANDAGE, ADHESIVE
Product CodeKGX
Date Received2020-03-31
Catalog Number36361361
Lot Number201912
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW MEDICAL LTD.
Manufacturer Address101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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