MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-10 for STUBBY RECTAL THERMOMETER FMF-105X manufactured by Faichney Medical Co..
[24406]
Letter from child's father indicates that thermometer's tip broke off inside his daughter's rectum. Child was taken to hosp for x-rays.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1483039-1996-00012 |
| MDR Report Key | 34876 |
| Date Received | 1996-07-10 |
| Date of Report | 1996-07-08 |
| Date of Event | 1996-06-07 |
| Date Facility Aware | 1996-07-02 |
| Report Date | 1996-07-08 |
| Date Reported to FDA | 1996-07-09 |
| Date Reported to Mfgr | 1996-07-09 |
| Date Added to Maude | 1996-08-05 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | STUBBY RECTAL THERMOMETER |
| Generic Name | RECTAL THERMOMETER |
| Product Code | FLK |
| Date Received | 1996-07-10 |
| Model Number | NA |
| Catalog Number | FMF-105X |
| Lot Number | BA-2-A |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 36260 |
| Manufacturer | FAICHNEY MEDICAL CO. |
| Manufacturer Address | 17159 SURREY VIEW DR CHESTERFIELD MO 63005 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1996-07-10 |