MEPILEX / BORDER POST-OP AG SILICONE DRESSING 498600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for MEPILEX / BORDER POST-OP AG SILICONE DRESSING 498600 manufactured by Molnlycke Healthcare Us Llc.

Event Text Entries

[180768289] Mepilex border post-op ag, 4" x 12" dressing was noted to have a tannish / brown coloration when it was opened at the end of the case. This dressing was not used and replaced with another dressing that had the normal grayish color. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093164
MDR Report Key9739430
Date Received2020-02-20
Date of Report2020-02-18
Date of Event2020-02-11
Date Added to Maude2020-02-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEPILEX / BORDER POST-OP AG SILICONE DRESSING
Generic NameDRESSING, WOUND, DRUG
Product CodeFRO
Date Received2020-02-20
Model Number498600
Catalog Number498600
Lot Number19319608
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMOLNLYCKE HEALTHCARE US LLC
Manufacturer AddressNORCROSS GA 30092 US 30092


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-20

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