MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-03-11 for BD ORAL GLASS THERMOMETER 524015 manufactured by Becton Dickinson.
[1047271]
Parent of child reported he took his child's temperature using bd oral mercury glass thermometer and child bit it and thermometer broke in the child's mouth. Call was disconnected as father was taking child for medical attention.
Patient Sequence No: 1, Text Type: D, B5
[8254465]
No product return is anticipated as complaint indicates that the product has been discarded. Unable to run complaint history check or device history review as lot number is unk. Regulatory compliance will continue to monitor on monthly trend reports.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243072-2009-00007 |
| MDR Report Key | 1343840 |
| Report Source | 04 |
| Date Received | 2009-03-11 |
| Date of Report | 2009-03-10 |
| Date of Event | 2009-02-11 |
| Date Mfgr Received | 2009-02-11 |
| Date Added to Maude | 2009-03-19 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY SHENOUDA |
| Manufacturer Street | ONE BECTON DR M/C 368 |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 2018475140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD ORAL GLASS THERMOMETER |
| Generic Name | THERMOMETER |
| Product Code | FLK |
| Date Received | 2009-03-11 |
| Model Number | NA |
| Catalog Number | 524015 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | ONE BECTON DR FRANKLIN LAKES NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-11 |