MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2004-10-11 for LICOX OXYGEN MICRO-PROBE * CC1.SB manufactured by Gesellschaft Fur Medizinische Sondentech.
[686730]
Catheter showed wrong reading. Exchanged for new catheter and reading was fine. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8127829]
To date, the device has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617494-2004-00027 |
| MDR Report Key | 888307 |
| Report Source | 01,05,06 |
| Date Received | 2004-10-11 |
| Date of Report | 2004-10-11 |
| Date Mfgr Received | 2004-08-31 |
| Date Added to Maude | 2007-08-02 |
| 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 | 0 |
| Manufacturer Contact | JENNA KARABAS |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362236 |
| Manufacturer G1 | GESELLSCHAFT FUR MEDIZINISCHE SONDENTECH |
| Manufacturer Street | DORFSTRABE 2A |
| Manufacturer City | KEIL-MIELKENDORF 24247 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 24247 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LICOX OXYGEN MICRO-PROBE |
| Generic Name | LICOX BRAIN TISSUE OXYGEN MONITORING |
| Product Code | CCE |
| Date Received | 2004-10-11 |
| Model Number | * |
| Catalog Number | CC1.SB |
| Lot Number | NOT KNOWN |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 865719 |
| Manufacturer | GESELLSCHAFT FUR MEDIZINISCHE SONDENTECH |
| Manufacturer Address | * KIEL-MIELKENDORF * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-11 |