MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-02-25 for DEROYAL ESOPHAGEAL STETHESCOPE * 81-040409 manufactured by Deroyal Industries, Inc..
[178292]
Esophageal stethescope was removed from pt. The pt was still intubated and upon suctioning, it was noticed that the blue plastic tip was left in the back of the pt's throat. Dr was able to remove tip from pt's throat. The pt was not injured as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1046367-2000-00011 |
| MDR Report Key | 266245 |
| Report Source | 06 |
| Date Received | 2000-02-25 |
| Date of Report | 2000-02-21 |
| Date of Event | 2000-01-12 |
| Date Facility Aware | 2000-01-12 |
| Report Date | 2000-02-21 |
| Date Reported to FDA | 2000-02-21 |
| Date Mfgr Received | 2000-01-25 |
| Date Added to Maude | 2000-03-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL ESOPHAGEAL STETHESCOPE |
| Generic Name | ESOPHAGEAL STETHESCOPE |
| Product Code | BZT |
| Date Received | 2000-02-25 |
| Returned To Mfg | 2000-02-01 |
| Model Number | * |
| Catalog Number | 81-040409 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 257744 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | ESOPHAGEAL STETHOSCOPE |
| Baseline Generic Name | ESOPHAGEAL STETHOSCOPE |
| Baseline Model No | NA |
| Baseline Catalog No | 81-040409 |
| Baseline ID | NA |
| Baseline Device Family | ESOPHAGEAL STETHOSCOPE |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K925789 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-02-25 |