MAUDE Adverse Event Report: OYSTERSHELL NV RID SUPER MAX 4 IN 1 COMPLETE LICE ELIMINATION KIT; LICE REMOVAL KIT

Device Problem Insufficient Information (3190)

Patient Problems Hair Loss (1877); Pain (1994); Scar Tissue (2060); Caustic/Chemical Burns (2549); Localized Skin Lesion (4542); Skin Infection (4544)

Event Date 12/04/2022

Event Type  Injury  

Event Description

On (b)(6) 2023, a spontaneous report from the united states was received via email regarding a 59-year-old female who used rid super max 4 in 1 complete lice elimination kit.On (b)(6) 2023, additional information was received which was incorporated into this report.Medical history included chronic neck pain, chronic back pain, seasonal allergies, an unspecified disability.The consumer used products to bleach and color her hair prior to the use of rid super max 4 in 1.Between (b)(6) 2022 and (b)(6) 2022, she also used numerous lice treatments including home remedies, lice shampoos, and lice treatment sprays including the use of a homeopathic lice treatment spray for an extended period.She reported to still have lice.On (b)(6) 2022, the consumer applied rid super max 4 in 1 complete lice elimination kit to her hair for lice.The consumer reported that she had severe chemical burns which burnt holes in her scalp, the rinse burnt her face (she did not apply on her face), she developed an infection, and had permanent hair loss.On 12-(b)(6) 2023, the consumer provided a description of the event; she reported applying the rid solution to her hair for 10 minutes, rinsing once with her normal daily shampoo and water and then washing her with dawn dishwashing liquid.After feeling a burning sensation, the consumer proceeded to rinse her hair/scalp with vinegar to "neutralize" the product.There were some inconsistencies in the details provided by the consumer.For example, in one account the consumer reported that the water and product did run onto her face, and in an earlier statement she claimed that the product burned her face "without getting any on her face." the consumer reported waking the next morning on (b)(6) 2022 with her eyes swollen shut and styes on every lash on her upper and lower lids of both eyes.She had "boils" on her scalp, back of her neck, and on her left cheek that were painful and would expel puss after touching.She called her doctor who advised her to go to an urgent care.At the urgent care, she reports being diagnosed as having chemical burns, to unspecified locations and was prescribed oral ciprofloxacin, ciprofloxacin eye drops, and prednisone.She took the medications as directed.On (b)(6) 2022, she followed up with her primary health care provider.The provider advised for her to continue the previously prescribed medications, and recommended she use oil of olay on her face.She had since refilled the ciprofloxacin (oral and eye drops) three times.As of (b)(6) 2023, she had new boils and styes that developed frequently.She washed her hands with rubbing alcohol to sterilize them and proceeded to squeeze the pus out from the boils.She then applied hydrogen peroxide and applied a topical acne medication to the open sore.The boils would scab over and turn into scars.She stated she developed a large bald patch on the crown of her head.When a new stye formed, she removed the affected eyelash so the area could drain.The consumer also continued to report having lice and that the rid product was not effective in eradication.She continues to use an unspecified lice shampoo and nit comb daily.

Manufacturer Narrative

This report is made by oystershell without prejudice and does not imply any admission or liability for the incident or its consequences.Consumer reported having "super lice" since (b)(6) 2022 and used multiple home remedies and multiple lice products from (b)(6) 2022 to (b)(6) 2022, including use of a homeopathic lice treatment spray daily for an extended period.She stated she used the rid product for the first time in (b)(6) 2022, after applying rid, the consumer described rinsing her hair, and then applying household products - a dishwashing liquid detergent followed by vinegar to her hair and scalp.The consumer further stated, she treated her skin irritation with hydrogen peroxide followed by an acne treatment cream.The lot number provided by the consumer is not a valid lot number for this rid product.A follow-up call was made to the consumer to obtain additional product information and consumer was unwilling to provide any additional information.Accordingly an investigation cannot be initiated.

• Brand Name: RID SUPER MAX 4 IN 1 COMPLETE LICE ELIMINATION KIT
• Type of Device: LICE REMOVAL KIT
• Manufacturer (Section D): OYSTERSHELL NV; 409 east lancaster avenue; wayne PA 19087
• Manufacturer (Section G): OYSTERSHELL CONSUMER HEALTH; 409 east lancaster avenue; wayne PA 19087
• Manufacturer Contact: mike van ganse ; 409 east lancaster avenue; wayne, PA 19087 ; 6109719600
• MDR Report Key: 16294032
• MDR Text Key: 308819175
• Report Number: 3004416964-2023-00001
• Device Sequence Number: 1
• Product Code: LJL
• UDI-Device Identifier: 00810061048114
• UDI-Public: 810061048114
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GABAPENTIN; MULTIVITAMIN; OMEPRAZOLE; OXYCODONE; UNSPECIFIED MUSCLE RELAXANT
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female