MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-06-29 for FASTEMP RECTAL ISO - CHAMBER 202036 manufactured by Tyco Healthcare / Kendall.
[21695082]
It was reported to tyco healthcare/kendall on 6/14/2006 that a customer has a problem with a fastemp rectal thermometer. The customer stated that "the measuring probe had burst. " this happened during the measuring process. The hospital put a sleeve/cover over the fastemp. After removing the fastemp they realized that the tip of the probe had exploded and the measuring sensor was open.
Patient Sequence No: 1, Text Type: D, B5
[21866141]
An investigation is currently underway, results will be forwarded upon completion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1310379-2006-00014 |
| MDR Report Key | 734293 |
| Report Source | 06 |
| Date Received | 2006-06-29 |
| Date of Report | 2006-06-14 |
| Date Reported to Mfgr | 2006-06-14 |
| Date Mfgr Received | 2006-06-14 |
| Date Added to Maude | 2006-07-17 |
| 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 | FASTEMP RECTAL ISO - CHAMBER |
| Generic Name | RECTAL THERMOMETER |
| Product Code | FLK |
| Date Received | 2006-06-29 |
| Model Number | 202036 |
| Catalog Number | 202036 |
| Lot Number | SN: G0516359 |
| 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 | 722164 |
| Manufacturer | TYCO HEALTHCARE / KENDALL |
| Manufacturer Address | 986 FAICHNEY DRIVE WATERTOWN NY 13601 US |
| Baseline Brand Name | FASTEMP RECTAL ISO - CHAMBER |
| Baseline Generic Name | RECTAL THERMOMETER |
| Baseline Model No | 202036 |
| Baseline Catalog No | 202036 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-29 |