MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-11 for ENHANCED EXTERNAL COUNTER-PULSATION MC2 manufactured by Foshan Life Sciences.
[15446474]
Prior to beginning the pt's first eecp therapy session, the pt took ntg sublingual to releive typical and mild angina. Eight minutes into the therapy session, the pt reported no chest pain. Twenty minutes into the therapy session, pulse increased, oxygen saturation decreased to 86% and shortness of breath developed. Oxygen and diuretics were administered at the office. The pt was then admitted to the hospital with a diagnosis of flash pulmonary edema and unstable angina. Within 48 hours the pt was removed from the ventilator and icu. Six days later the pt was discharged. An mi was diagnosed as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435300-2002-00007 |
| MDR Report Key | 407001 |
| Date Received | 2002-07-11 |
| Date of Report | 2002-07-11 |
| Date of Event | 2002-07-03 |
| Date Facility Aware | 2002-07-05 |
| Report Date | 2002-07-11 |
| Date Reported to Mfgr | 2002-07-11 |
| Date Added to Maude | 2002-07-29 |
| 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 | 0 |
| 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 | 2002-07-11 |
| Model Number | MC2 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2.5 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 395992 |
| Manufacturer | FOSHAN LIFE SCIENCES |
| Manufacturer Address | 6 HARBOR ROAD FOSHAN CITY, GUANG DONG CH 528000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2002-07-11 |