MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-09 for SCOPE7 LARYNGOSCOPE manufactured by Unk.
[49565709]
At that doctor's visit, the scope was used. Since then, a very painful sore throat developed slowly and worked further down the throat and "infection" (right side predominantly) - difficulty swallowing, etc. No symptoms were present before the scope was used. Either or both, the scope was jammed down improperly and/or there was an infection on it that was not cleaned off. They put me on a ten-day antibiotic (levofloxacin) which did nothing to help at all. Then, a ten-day (stronger) antibiotic (amox and clavulanate potassium) (875 mg 2/day) plus prednisone. Throat has gotten only slightly better, while other symptoms are worse. Symptoms are now: sore throat; difficulty swallowing; difficulty getting up congestion / hard to clear throat (cilia damage? ); sleeplessness; other cold-like symptoms (weak, aches, sneezing, cough, inflammation of mucosa, etc. ).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063361 |
| MDR Report Key | 5790450 |
| Date Received | 2016-07-09 |
| Date of Report | 2016-07-09 |
| Date of Event | 2016-05-09 |
| Date Added to Maude | 2016-07-13 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SCOPE7 LARYNGOSCOPE |
| Generic Name | LARYNGOSCOPE |
| Product Code | CAL |
| Date Received | 2016-07-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-07-09 |