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 Number: MW5093841
• MDR Report Key: 9853361
• Date Received: 2020-03-18
• Date of Report: 2020-03-17
• Date of Event: 2020-03-17
• Date Added to Maude: 2020-03-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MEPILEX BORDER POST-OP AG DRESSING
• Generic Name: DRESSING, WOUND, DRUG
• Product Code: FRO
• Date Received: 2020-03-18
• Model Number: 498600
• Catalog Number: 498600
• Lot Number: 19350324
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MOLNLYCKE HEALTH CARE, INC.
• Manufacturer Address: NORCROSS GA 30092 US 30092

Device Sequence Number: 2

• Brand Name: MEPILEX BORDER POST-OP AG DRESSING
• Generic Name: DRESSING, WOUND, DRUG
• Product Code: FRO
• Date Received: 2020-03-18
• Model Number: 498600
• Catalog Number: 498600
• Lot Number: 19350324
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MOLNLYCKE HEALTH CARE, INC.

Device Sequence Number: 3

• Brand Name: MEPILEX BORDER POST-OP AG DRESSING
• Generic Name: DRESSING, WOUND, DRUG
• Product Code: FRO
• Date Received: 2020-03-18
• Model Number: 498600
• Catalog Number: 498600
• Lot Number: 19480491
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MOLNLYCKE HEALTH CARE, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-18