MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-12-05 for ENHANCED EXTERNAL COUNTERPULSATION TS3 * manufactured by Vasomedical Inc..
[359607]
Approximately 3 months after completion of the therapy the pt reported a hernia repair operation. The pt reports that the hernia occurred during one of the sessions. Therapist states that no report was made during the course of therapy, except for one report of left upper quadrant discomfort in which pressure was decreased in order to relieve discomfort. Surgery to repair hernia was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435300-2003-00015 |
| MDR Report Key | 500209 |
| Report Source | 07 |
| Date Received | 2003-12-05 |
| Date of Report | 2003-12-05 |
| Date of Event | 2003-08-01 |
| Date Mfgr Received | 2003-11-25 |
| Device Manufacturer Date | 2003-02-01 |
| Date Added to Maude | 2003-12-12 |
| 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 | 2003-12-05 |
| Model Number | TS3 |
| Catalog Number | * |
| Lot Number | 3TC0430 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 488976 |
| Manufacturer | VASOMEDICAL INC. |
| Manufacturer Address | 180 LINDEN AVE. WESTBURY NY 11590 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. Hospitalization | 2003-12-05 |