MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-24 for OTOLAM manufactured by Sharplan Lasers, Inc..
[15035064]
Otolaryngologist who has been involved with the device review process for this device has "serious" concerns regarding the lack of long-term risk data on this device when used for repeated treatment of recurrent ear infections. Dr is also concerned that the device is being aggressively marketed toward non-surgically trained pediatricians and parents. Reporter states in his conversations with the mfr rep, the co plainly admits to not having data on the long-term effects of this procedure. There is no long-term safety data.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017622 |
| MDR Report Key | 251148 |
| Date Received | 1999-11-24 |
| Date of Report | 1999-11-24 |
| Date Added to Maude | 1999-11-29 |
| 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 | OTOLAM |
| Generic Name | CO2 LASER |
| Product Code | EWG |
| Date Received | 1999-11-24 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 243302 |
| Manufacturer | SHARPLAN LASERS, INC. |
| Manufacturer Address | ONE PEARL CT. ALLENDALE NJ 07401 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-24 |