MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-04-21 for SONATEMP ESOPHAGEAL STETHOSCOPE SERIES 400 * 5-13218 manufactured by Kendal Healthcare.
[21707391]
Qa management of medical center reports to sales rep of manufacturer that a patient was using an esophageal stethoscope manufactured by the mfr. Upon removal of product, customer alleges the end cap of product had dislodged from the main esophageal stethoscope. Twenty-four hours later, the patient vomited up the end piece of the stethoscope. As a result, the patient remained in hospital for observation and a full series of x-rays. No patient injury was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317749-2000-00002 |
| MDR Report Key | 275074 |
| Report Source | 07 |
| Date Received | 2000-04-21 |
| Date of Report | 2000-04-21 |
| Date of Event | 2000-03-23 |
| Date Facility Aware | 2000-03-23 |
| Report Date | 2000-03-23 |
| Date Reported to Mfgr | 2000-03-23 |
| Date Mfgr Received | 2000-03-27 |
| Date Added to Maude | 2000-04-27 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WARREN NIGHAN, RN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618155 |
| Manufacturer G1 | KENDALL SHERIDAN |
| Manufacturer Street | RT. 40 |
| Manufacturer City | ARYGLE NY 12809968 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12809 9684 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONATEMP ESOPHAGEAL STETHOSCOPE SERIES 400 |
| Generic Name | ESOPHAGEAL STETHOSCOPE |
| Product Code | BZW |
| Date Received | 2000-04-21 |
| Model Number | * |
| Catalog Number | 5-13218 |
| Lot Number | 104955 |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 266244 |
| Manufacturer | KENDAL HEALTHCARE |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Baseline Brand Name | SHERIDAN SONATEMP SCRICS 400 |
| Baseline Generic Name | ESOPHAGEAL STETHOSCOPE |
| Baseline Model No | NA |
| Baseline Catalog No | 5-13218 |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K841098 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-04-21 |