MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-09-25 for PARATREND 7 PARATREND 7 DPM MDM 7002 manufactured by Biomedical Sensors Ltd.
[38864]
Customer has reported anomalous readings. No report of injury has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612233-1996-90007 |
| MDR Report Key | 55208 |
| Report Source | 05,06 |
| Date Received | 1996-09-25 |
| Date of Report | 1996-09-24 |
| Date of Event | 1996-01-01 |
| Date Mfgr Received | 1996-09-13 |
| Device Manufacturer Date | 1993-01-01 |
| Date Added to Maude | 1996-12-16 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARATREND 7 |
| Generic Name | PATIENT DATA MODULE |
| Product Code | CCC |
| Date Received | 1996-09-25 |
| Model Number | PARATREND 7 DPM |
| Catalog Number | MDM 7002 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 55751 |
| Manufacturer | BIOMEDICAL SENSORS LTD |
| Manufacturer Address | GEORGE ST HIGH WYCOMBE, BUCKS UK HP11 2XJ |
| Baseline Brand Name | PARATREND 7 |
| Baseline Generic Name | PATIENT DATA MODULE |
| Baseline Model No | PARATREND 7 DPM |
| Baseline Catalog No | MDM 7002 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-09-25 |