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

Lot Number 30675

Device Problem Nonstandard Device (1420)

Patient Problem No Patient Involvement (2645)

Event Type  No Answer Provided  

Event Description

Lemon prep skin cleanser lot #30675 listed on mfr recall list.The product was removed and quarantined per mfr instructions.Product will be returned to mfr.Product was not used and unopened.

• Brand Name: LEMON PREP SKIN CLEANSER
• Type of Device: DEGREASER, SKIN, SURGICAL-CARDIO PREP
• Manufacturer (Section D): MAVIDON MEDICAL PRODUCTS
• MDR Report Key: 9174719
• MDR Text Key: 162311206
• Report Number: MW5090328
• Device Sequence Number: 1
• 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: Respiratory Therapist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 30675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1