MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-02 for BASIS EAR NOSE & THROAT MED-CHECK LIGHT * UNK manufactured by Polymedica Healthcare, Inc..
[18191316]
Adult male examined for questionable streptococcus infection by rptr. Rptr was unable to visualize the ear drums because the ear speculum and light were not aligned. (rptr had previously bought two other instruments which he tried on his wife and son with the same results. ) also: tongue depressors bend and are useless. Rptr urges that the product be withdrawn from the market. It is sold in pharmacies. Add'l event date 8/23/99. Rptr wrote to mfr about a defective light. Mfr's response was that its products were highly tested and guaranteed accurate. The kit rptr received was as a replacement. This is the third kit rptr has tried to use as an otoscope. None of them provide light on the tympanic membrane, using regular examination procedure of pulling the earlobe upward and posteriorly. Rptr is trained in otosocpic use. Rptr feels these kits are useless for ear examination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017299 |
| MDR Report Key | 244335 |
| Date Received | 1999-10-02 |
| Date of Report | 1999-10-01 |
| Date of Event | 1999-08-04 |
| Date Added to Maude | 1999-10-14 |
| 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 |
| Brand Name | BASIS EAR NOSE & THROAT MED-CHECK LIGHT |
| Generic Name | FIBEROPITC LIGHT, MAGNIFIER & EAR SPECULUM |
| Product Code | EPY |
| Date Received | 1999-10-02 |
| Model Number | * |
| Catalog Number | UNK |
| Lot Number | * |
| ID Number | 311314 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 236712 |
| Manufacturer | POLYMEDICA HEALTHCARE, INC. |
| Manufacturer Address | 720 CORPORATE CIRCLE, STE R GOLDEN CO 80401 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-10-02 |