MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-10 for LICEMEISTER COMB UNK manufactured by National Pediculosis Assoc..
[16280693]
Mfr writes to rptr, "thank you so much for getting back to us on this. We will overnight you replacements today but it will help if you could forward your mailing address asap. We will include a self-addressed stamped envelope with your replacements so that you can sent back the broken combs at our expense. We apologize for the inconvenience but we are anxious to take a look at the combs to see why they might have broken. " rptr writes to mfr, "after buying and using one of your combs only a couple of times the handle cracked and fell off. Went and bought another one, and after the first use the same thing happened. I would prefer not to buy another one because of price. Can i send these to you so they can be fixed or replaced? I do like the product because it works great on my daughter's very thick hair. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015504 |
| MDR Report Key | 207554 |
| Date Received | 1998-12-10 |
| Date of Report | 1998-12-10 |
| Date of Event | 1998-12-09 |
| Date Added to Maude | 1999-01-27 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 |
| Brand Name | LICEMEISTER COMB |
| Generic Name | COMB |
| Product Code | LJL |
| Date Received | 1998-12-10 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 201458 |
| Manufacturer | NATIONAL PEDICULOSIS ASSOC. |
| Manufacturer Address | 50 KEARNEY RD. NEEDHAM MA 02494 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-12-10 |