MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-07 for BECTON-DICKINSON 36L18267 (GD) UNK manufactured by Becton-dickinson.
[123776]
Per copy of correspondence dated 11/18/97 to mfr from parent of pt, after removing thermometer from pt rectum, it was discovered broken. Mercury found in bottom of box. Used previous evening successfully; parent unable to locate glass. Pt taken to dr's office to check rectum for broken glass.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 147044 |
| MDR Report Key | 147044 |
| Date Received | 1998-01-07 |
| Date of Report | 1997-12-10 |
| Date of Event | 1997-11-01 |
| Date Facility Aware | 1997-12-01 |
| Report Date | 1997-12-10 |
| Date Reported to Mfgr | 1997-12-10 |
| Date Added to Maude | 1998-02-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | BECTON-DICKINSON |
| Generic Name | TEMP-AWAY THERMOMETER KIT |
| Product Code | FLK |
| Date Received | 1998-01-07 |
| Model Number | 36L18267 (GD) |
| Catalog Number | UNK |
| Lot Number | UN |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 143308 |
| Manufacturer | BECTON-DICKINSON |
| Manufacturer Address | ONE BECTON DR., BLDG 2 FRANKLIN LAKES NJ 07417 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-01-07 |