MAUDE Adverse Event Report: MAVIDON MEDICAL PRODUCTS MAVIDON - LEMON PREP ; DEGREASER, SKIN, SURGICAL

Lot Number 31221

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2020

Event Type  malfunction  

Event Description

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).

• Brand Name: MAVIDON - LEMON PREP
• Type of Device: DEGREASER, SKIN, SURGICAL
• Manufacturer (Section D): MAVIDON MEDICAL PRODUCTS
• MDR Report Key: 9596255
• MDR Text Key: 175702443
• Report Number: MW5092299
• Device Sequence Number: 3
• Product Code: KOY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2020
• 9 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 31221
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other