MEPILEX BORDER POST-OP AG 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 2020-03-18 for MEPILEX BORDER POST-OP AG DRESSING 498600 manufactured by Molnlycke Health Care, Inc..

Event Text Entries

[184481159] Three mepilex border post-op ag dressing were opened and noted to be a tannish / brownish color around the edges. Two were from one lot number and one from another. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093841
MDR Report Key9853361
Date Received2020-03-18
Date of Report2020-03-17
Date of Event2020-03-17
Date Added to Maude2020-03-19
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 Sequence Number: 1

Brand NameMEPILEX BORDER POST-OP AG DRESSING
Generic NameDRESSING, WOUND, DRUG
Product CodeFRO
Date Received2020-03-18
Model Number498600
Catalog Number498600
Lot Number19350324
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMOLNLYCKE HEALTH CARE, INC.
Manufacturer AddressNORCROSS GA 30092 US 30092

Device Sequence Number: 2

Brand NameMEPILEX BORDER POST-OP AG DRESSING
Generic NameDRESSING, WOUND, DRUG
Product CodeFRO
Date Received2020-03-18
Model Number498600
Catalog Number498600
Lot Number19350324
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerMOLNLYCKE HEALTH CARE, INC.

Device Sequence Number: 3

Brand NameMEPILEX BORDER POST-OP AG DRESSING
Generic NameDRESSING, WOUND, DRUG
Product CodeFRO
Date Received2020-03-18
Model Number498600
Catalog Number498600
Lot Number19480491
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerMOLNLYCKE HEALTH CARE, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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