MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-30 for ENHANCED EXTERNAL COUNTER-PULSATION MC2 * manufactured by Foshan Life Sciences.
[319408]
After first treatment pt complained of "floaters" in both eyes, but worse in left eye. Pt received second treatment and continued to see "floaters. " ophthalmologist diagnosed a retinal tear. Tear was cauterized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435300-2004-00002 |
| MDR Report Key | 523984 |
| Date Received | 2004-04-30 |
| Date of Report | 2004-04-30 |
| Date of Event | 2004-04-08 |
| Date Facility Aware | 2004-04-09 |
| Report Date | 2004-04-30 |
| Date Added to Maude | 2004-05-10 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENHANCED EXTERNAL COUNTER-PULSATION |
| Generic Name | DEVICE, COUNTER-PULSATING, EXTERNAL |
| Product Code | DRN |
| Date Received | 2004-04-30 |
| Model Number | MC2 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 513110 |
| Manufacturer | FOSHAN LIFE SCIENCES |
| Manufacturer Address | * FOSHAN CITY CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-04-30 |