MEDI-COMB NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-29 for MEDI-COMB NI manufactured by Health Ent., Inc..

Event Text Entries

[128557] Child caught head lice at school. She was treated with appropriate shampoo and following the instructions on the comb, with one exception, the mother proceeded to comb through the child's hair and all of the hair in the comb was cut off. The one exception to the instructions was "using the right hand". The mother is left handed and therefore using the right hand would have been more awkward and damaging. The mother consulted her pediatrician and pharmacist to ensure that the incident was not related to the shampoo. Both hcp's reported no experience of this sort. In an attempt to rule out the shampoo, the mother repeated the procedure on her own hair using regular shampoo. The result was the same, her hair was cut off by the comb. The rptr stated, the device mfr told her that the incident occurred because she had used her left hand. The rptr finds this to be unacceptable and feels that there should be add'l labeling or the product should be removed from the market. Rptr states the only warning on the product is "do not force medi-comb through hair. Use caution to avoid scratching the scalp. " the pharmacy, the rptr purchased the comb from removed the stock from her shelf after examining the comb and finding it to be sharp.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1016220
• MDR Report Key: 221311
• Date Received: 1999-04-29
• Date of Report: 1999-04-29
• Date of Event: 1999-04-27
• Date Added to Maude: 1999-05-04
• 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
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDI-COMB
• Generic Name: METAL LICE COMB
• Product Code: LJL
• Date Received: 1999-04-29
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: LAY USER/PATIENT
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 214610
• Manufacturer: HEALTH ENT., INC.
• Manufacturer Address: 90 GEORGE LEVEN DR. N. ATTLEBORO MA 02760 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-04-29