MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-28 for PENTEX FNL-10RP3 manufactured by Pentex.
[19910373]
Machidascope tip touched the drape & burned a small spot in 2 areas. The tip of scope was very hot to the touch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012883 |
| MDR Report Key | 1488135 |
| Date Received | 2009-09-28 |
| Date of Report | 2009-09-23 |
| Date of Event | 2009-09-01 |
| Date Added to Maude | 2009-10-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENTEX |
| Generic Name | "MACHIDASCOP" FIBER NASOPHARYHGO LARYNGOSCOPE |
| Product Code | EQN |
| Date Received | 2009-09-28 |
| Model Number | FNL-10RP3 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENTEX |
| Manufacturer Address | 102 CHESTNUT RIDGE RD MONTVALE NJ 07645 US 07645 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-28 |