MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-04-28 for ENHANCED EXTERNAL COUNTERPULSATION TS3 manufactured by Vasomedical, Inc..
[311539]
During and after the 17th treatment session, the pt complained of blurred vision in the right eye. Normal vision returned a few hours later. No problems were reported during the 18th treatment session. During the 19th treatment session, the pt complained of blurred and double vision in the right eye. Pt saw an ophthalmologist and was diagnosed with macular edema. Normal vision returned within a few hours without intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435300-2004-00001 |
| MDR Report Key | 556859 |
| Report Source | 07 |
| Date Received | 2004-04-28 |
| Date of Report | 2004-04-28 |
| Date of Event | 2004-04-08 |
| Date Mfgr Received | 2004-04-19 |
| Date Added to Maude | 2004-12-01 |
| 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 | THOMAS VARRICCHIONE |
| Manufacturer Street | 180 LINDEN AVE. |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 5169974600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENHANCED EXTERNAL COUNTERPULSATION |
| Generic Name | DEVICE, COUNTER-PULSATING, EXTERNAL |
| Product Code | DRN |
| Date Received | 2004-04-28 |
| Model Number | TS3 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 546528 |
| Manufacturer | VASOMEDICAL, INC. |
| Manufacturer Address | * WESTBURY NY * US |
| Baseline Brand Name | EECP THERAPY SYSTEM |
| Baseline Generic Name | EECP |
| Baseline Model No | TS3 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | DEVICE, COUNTER-PULSATING, EXTERNAL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K003469 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-28 |