MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-04 for INFANT THEROMETER UNK manufactured by Faichney Medical Company.
[59370]
The bulb of the thermometer broke off in infant's rectum after taking a rectal temperature. Bleeding was then noticed coming from her rectum. She was taken to the hosp where they did a rectal exam and induced bowel movement in an attempt to see if there was any more glass or mercury left in the rectum. There was, which the inducement of bowel movements cleared. The infant was discharged within 3-4 hours with no further treatment. Bleeding with bowel movements was observed for the next two days. She has since been seen by a doctor and no further prolbems and no further treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000008-1997-00014 |
| MDR Report Key | 95455 |
| Date Received | 1997-06-04 |
| Date of Report | 1997-06-04 |
| Date of Event | 1997-05-26 |
| Date Facility Aware | 1997-06-03 |
| Report Date | 1997-06-04 |
| Date Reported to FDA | 1997-06-04 |
| Date Reported to Mfgr | 1997-06-04 |
| Date Added to Maude | 1997-06-05 |
| 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 |
| Reporter Occupation | UNKNOWN |
| 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 | INFANT THEROMETER |
| Generic Name | THERMOMETER |
| Product Code | FLK |
| Date Received | 1997-06-04 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 94248 |
| Manufacturer | FAICHNEY MEDICAL COMPANY |
| Manufacturer Address | 11611 FAIRGROVE INDUSTRIAL MARYLAND HTS MO 63043 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-06-04 |