MAVIDON - LEMON PREP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for MAVIDON - LEMON PREP manufactured by Mavidon Medical Products.

Event Text Entries

[175702443] Mavidon issues voluntary worldwide recall of manufactured products including lemonprep tubes, single use cups pediaprep tubes, single use cups wave prep tubes, and single use cups cardio prep single use cups due to burkholderia cepacia contamination. We have 9 tubes of lemon prep abrasive skin prepping gel, 6 of lot # 31221, and 3 of lot # 30983. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092299
• MDR Report Key: 9596255
• Date Received: 2020-01-15
• Date of Report: 2020-01-13
• Date of Event: 2020-01-13
• Date Added to Maude: 2020-01-16
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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: MAVIDON - LEMON PREP
• Generic Name: DEGREASER, SKIN, SURGICAL
• Product Code: KOY
• Date Received: 2020-01-15
• Lot Number: 31221
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MAVIDON MEDICAL PRODUCTS

Device Sequence Number: 2

• Brand Name: MAVIDON - LEMON PREP
• Generic Name: DEGREASER, SKIN, SURGICAL
• Product Code: KOY
• Date Received: 2020-01-15
• Lot Number: 31221
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MAVIDON MEDICAL PRODUCTS

Device Sequence Number: 3

• Brand Name: MAVIDON - LEMON PREP
• Generic Name: DEGREASER, SKIN, SURGICAL
• Product Code: KOY
• Date Received: 2020-01-15
• Lot Number: 31221
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MAVIDON MEDICAL PRODUCTS

Device Sequence Number: 4

• Brand Name: MAVIDON - LEMON PREP
• Generic Name: DEGREASER, SKIN, SURGICAL
• Product Code: KOY
• Date Received: 2020-01-15
• Lot Number: 31221
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: MAVIDON MEDICAL PRODUCTS

Device Sequence Number: 5

• Brand Name: MAVIDON - LEMON PREP
• Generic Name: DEGREASER, SKIN, SURGICAL
• Product Code: KOY
• Date Received: 2020-01-15
• Lot Number: 31221
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: MAVIDON MEDICAL PRODUCTS

Device Sequence Number: 6

• Brand Name: MAVIDON - LEMON PREP
• Generic Name: DEGREASER, SKIN, SURGICAL
• Product Code: KOY
• Date Received: 2020-01-15
• Lot Number: 31221
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: MAVIDON MEDICAL PRODUCTS

Device Sequence Number: 7

• Brand Name: MAVIDON - LEMON PREP
• Generic Name: DEGREASER, SKIN, SURGICAL
• Product Code: KOY
• Date Received: 2020-01-15
• Lot Number: 30983
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: MAVIDON MEDICAL PRODUCTS

Device Sequence Number: 8

• Brand Name: MAVIDON - LEMON PREP
• Generic Name: DEGREASER, SKIN, SURGICAL
• Product Code: KOY
• Date Received: 2020-01-15
• Lot Number: 30983
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 8
• Device Event Key: 0
• Manufacturer: MAVIDON MEDICAL PRODUCTS

Device Sequence Number: 9

• Brand Name: MAVIDON - LEMON PREP
• Generic Name: DEGREASER, SKIN, SURGICAL
• Product Code: KOY
• Date Received: 2020-01-15
• Lot Number: 30983
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 9
• Device Event Key: 0
• Manufacturer: MAVIDON MEDICAL PRODUCTS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-01-15