MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-28 for THERMOMETER S01-06009018 AP058 211869 manufactured by General Medical Corp..
[102011]
Thermometer had air gap in mercury column that would not "shake down". The product was replaced with no known pt sequelae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012370 |
| MDR Report Key | 128595 |
| Date Received | 1997-10-28 |
| Date of Report | 1997-10-28 |
| Date of Event | 1997-10-24 |
| Date Added to Maude | 1997-10-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOMETER |
| Generic Name | THERMOMETER, MERCURY |
| Product Code | FLK |
| Date Received | 1997-10-28 |
| Model Number | S01-06009018 AP058 |
| Catalog Number | 211869 |
| Lot Number | 1-7 TEM-CON |
| ID Number | 4284 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 125797 |
| Manufacturer | GENERAL MEDICAL CORP. |
| Manufacturer Address | 1249 AVE, "R" GRAND PRAIRIE TX 75050 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-28 |