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 1998-01-29 for PARATREND 7 SENSOR MPS7004 manufactured by Diametrics Medical, Ltd..
[122436]
Blood leaked during insertion of the sensor. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612233-1998-90002 |
| MDR Report Key | 146501 |
| Report Source | 01,05,06 |
| Date Received | 1998-01-29 |
| Date of Report | 1998-01-27 |
| Date of Event | 1997-12-16 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 1998-02-03 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARATREND 7 SENSOR |
| Generic Name | BLOOD GAS MONITORING SYSTEM |
| Product Code | CCC |
| Date Received | 1998-01-29 |
| Model Number | MPS7004 |
| Catalog Number | MPS7004 |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 1998-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 142785 |
| Manufacturer | DIAMETRICS MEDICAL, LTD. |
| Manufacturer Address | GEORGE ST. HIGH WYCOMBE, BUCKS. UK HP11 2XJ |
| Baseline Brand Name | PARATREND 7 SENSOR |
| Baseline Generic Name | BLOOD GAS MONITORING SYSTEM |
| Baseline Model No | MPS7004 |
| Baseline Catalog No | MPS7004 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-01-29 |