MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-12-18 for FILAC FASTEMP MONITOR ONLY 202018 manufactured by Tyco Healthcare/kendal.
[541050]
It was reported to tyco healthcare/kendall that a customer had a problem with a thermometer probe. The customer stated that the probe got so hot it melted the probe covers.
Patient Sequence No: 1, Text Type: D, B5
[7942558]
An investigation is currently underway, upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1310379-2006-00027 |
| MDR Report Key | 798771 |
| Report Source | 06 |
| Date Received | 2006-12-18 |
| Date of Report | 2006-12-05 |
| Date Reported to Mfgr | 2006-12-05 |
| Date Mfgr Received | 2006-12-05 |
| Date Added to Maude | 2006-12-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| Manufacturer G1 | TYCO HEALTHCARE / KENDALL |
| Manufacturer Street | 986 FAICHNEY DRIVE |
| Manufacturer City | WATERTOWN NY 13601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILAC FASTEMP MONITOR ONLY |
| Generic Name | THERMOMETER |
| Product Code | FLK |
| Date Received | 2006-12-18 |
| Model Number | 202018 |
| Catalog Number | 202018 |
| Lot Number | UNK |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 786299 |
| Manufacturer | TYCO HEALTHCARE/KENDAL |
| Manufacturer Address | 986 FAICHNEY DR. WATERTOWN NY 13601 US |
| Baseline Brand Name | FILAC FASTEMP MONITOR ONLY |
| Baseline Generic Name | THERMOMETER |
| Baseline Model No | 202018 |
| Baseline Catalog No | 202018 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-18 |