MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-27 for CF INDICATOR 9800 * manufactured by Medtronic Inc..
[218259]
Sweat test ordered. Device in place 8 minutes. When removed, rt and parent noted 5 3-4mm areas on liner aspect of left thigh that was diagnosed as 2nd degree burns.
Patient Sequence No: 1, Text Type: D, B5
[233777]
Add'l info rec'd from reporter 09/05/2001: product-device not applied according to mfr's guidelines. Corrective action in place. Mfr notified 09/05/01.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 349673 |
| MDR Report Key | 349673 |
| Date Received | 2001-08-27 |
| Date of Report | 2001-08-27 |
| Date of Event | 2001-08-24 |
| Date Facility Aware | 2001-08-24 |
| Report Date | 2001-08-27 |
| Date Reported to FDA | 2001-08-27 |
| Date Reported to Mfgr | 2001-08-27 |
| Date Added to Maude | 2001-09-05 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | CF INDICATOR |
| Generic Name | CONTROLLER KIT |
| Product Code | KTB |
| Date Received | 2001-08-27 |
| Model Number | 9800 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 338977 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | 7000 CENTRAL AVE NE MINNEAPOLIS MN 55432 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-08-27 |