MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1999-05-06 for CPD COMMANDER CPD200 manufactured by Scieran Technologies.
[156484]
During the fourth case of the day the product reportedly lost pressure and would not respond to attempts to increase the pressure. As a result the operative eye collapsed and a choroidal hemorrhage occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085836-1999-00001 |
| MDR Report Key | 222232 |
| Report Source | 06,07 |
| Date Received | 1999-05-06 |
| Date of Report | 1999-05-06 |
| Date of Event | 1999-04-08 |
| Date Facility Aware | 1999-04-08 |
| Report Date | 1999-04-28 |
| Date Mfgr Received | 1999-04-08 |
| Device Manufacturer Date | 1998-05-01 |
| Date Added to Maude | 1999-05-11 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CPD COMMANDER |
| Generic Name | CONTROLLED PRESSURE DELIVERY UNIT |
| Product Code | LCC |
| Date Received | 1999-05-06 |
| Returned To Mfg | 1999-04-19 |
| Model Number | CPD200 |
| Catalog Number | CPD200 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 215527 |
| Manufacturer | SCIERAN TECHNOLOGIES |
| Manufacturer Address | 27071 CABATO RD. STE 127 LAGUNA HILLS CA 92653 US |
| Baseline Brand Name | CPD COMMANDER |
| Baseline Generic Name | CONTROLLED PRESSURE DELIVERY UNIT |
| Baseline Model No | CPD200 |
| Baseline Catalog No | CPD200 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-05-06 |