MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-28 for KENDALL SHERIDAN SONATEMP SERIES 700 CAT. #5-132185218 FR manufactured by The Kendall Company Lp.
[151982]
Pt is s/p left upper lung resection, done on 03/22/2000. An esophageal stethoscope size 18 french was inserted prior to surgery and removal after surgery. This device is an anesthesia product for temperature monitoring. The next day 03/23/2000, pt vomitted while drinking soup and brought up a latex cap. This cap apparently came off (separated) from catheter probe. The cap is 2 inches long and appears to be glued on. The pt showed no significant or observed complications from this product problem. The mfr, kendall, was contacted and a rep came on 03/24/2000 to evaluate and fill a complaint report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 271247 |
| MDR Report Key | 271247 |
| Date Received | 2000-03-28 |
| Date of Report | 2000-03-27 |
| Date of Event | 2000-03-23 |
| Date Facility Aware | 2000-03-23 |
| Report Date | 2000-03-27 |
| Date Reported to FDA | 2000-03-28 |
| Date Reported to Mfgr | 2000-03-24 |
| Date Added to Maude | 2000-03-30 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL SHERIDAN |
| Generic Name | ESOPHAGEAL STETHOSCOPE - SONATEMP |
| Product Code | BZW |
| Date Received | 2000-03-28 |
| Model Number | SONATEMP SERIES 700 |
| Catalog Number | CAT. #5-132185218 FR |
| Lot Number | 104955 |
| ID Number | * |
| Device Expiration Date | 2004-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 262579 |
| Manufacturer | THE KENDALL COMPANY LP |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-03-28 |