MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-05-05 for THERMOMETER W/ PENCIL CASE, REC MDS70365 * manufactured by Medline Industries, Inc..
[180193]
Reportedly the tip of the rectal thermometer came off when being used on an infant. X-rays were taken and were negative for either glass or metal. The pt was monitored for 24 hours and there were no adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2000-00014 |
| MDR Report Key | 276776 |
| Report Source | 06 |
| Date Received | 2000-05-05 |
| Date of Report | 2000-05-04 |
| Date of Event | 2000-04-19 |
| Date Facility Aware | 2000-04-20 |
| Report Date | 2000-05-04 |
| Date Reported to FDA | 2000-05-04 |
| Date Reported to Mfgr | 2000-05-04 |
| Date Added to Maude | 2000-05-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8479493109 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOMETER W/ PENCIL CASE, REC |
| Generic Name | * |
| Product Code | FLK |
| Date Received | 2000-05-05 |
| Returned To Mfg | 2000-04-21 |
| Model Number | MDS70365 |
| Catalog Number | * |
| Lot Number | 906M1303/907M1303 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 267901 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 60060 US |
| Baseline Brand Name | THERMOMETER W/ PENCIL CASE, REC |
| Baseline Generic Name | * |
| Baseline Model No | MDS70365 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-05-05 |