LASSY LEGS 53KF99

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-17 for LASSY LEGS 53KF99 manufactured by Tee Vee Brands Int'l Ltd..

Event Text Entries

[2570318] A (b)(6) female complainant with known allergy to penicillin and taking three medications for high blood pressure, high cholesterol and heart burn reported incident after using tee vee brands lassy legs. Complainant has used similar brands for years without incident. Product is used to remove hair from arms, legs and mustache. Complainant has been using product every two weeks and shopping at same retail store over two years. She last used product in (b)(6) without issue. On (b)(6) 2011, complainant used product as normal on her arms and knuckles. No other creams or lotions were applied to her skin per complainant, this was the only product she applied to her skin. The next day, her right arm was red. The following day symptoms worsened and her right arm was more discolored. By the third day her right arm had swelled and appeared burned from her elbow to her wrist. She also had sacks of pus in small bumps on her skin. Complainant visited her doctor and was referred to the burn unit for abrasions to her external skin. She was treated with silver sulfate 1% and pain relievers. They wrapped her arm and she was told to apply cream twice per day. Symptoms have improved. Retailer name: (b)(6). Purchase date: (b)(6) 2011. Product used every two weeks.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5023827
• MDR Report Key: 2421557
• Date Received: 2012-01-17
• Date of Report: 2011-11-15
• Date of Event: 2011-11-05
• Date Added to Maude: 2012-01-24
• 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: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LASSY LEGS
• Generic Name: HAIR REMOVER
• Product Code: KCX
• Date Received: 2012-01-17
• Catalog Number: 53KF99
• Lot Number: 14429
• ID Number: 639277044297
• Operator: LAY USER/PATIENT
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TEE VEE BRANDS INT'L LTD.
• Manufacturer Address: 1210-C 12/F HARBOUR CTR TOWER KOWLOON CH

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-01-17