MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2016-01-22 for FLEX BELT 399 0390-5060 manufactured by Bio-medical Research Ltd.
[36594057]
Consumer reported suffering chest pain while using her flex belt device. Her cardiologist advised her she did not have coronary disease. No medical report was provided by the consumer. Device was evaluated and passed all testing. There were no faults found. Device history records for the device showed no major issues in the manufacturing process for this device. Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[36594058]
Consumer reported using the flex belt device one time for 7 minutes and began having severe chest pains. She turned off the unit and stated 'this resulted in a heart attack'. She visited her cardiologist and after being tested was advised she did not have coronary disease. The consumer requested a refund.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00030 |
| MDR Report Key | 5384859 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2016-01-22 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-07-31 |
| Date Mfgr Received | 2015-09-03 |
| Device Manufacturer Date | 2015-03-27 |
| Date Added to Maude | 2016-01-22 |
| 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 | 3 |
| Manufacturer Contact | MS ANDREA SMALL |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST GALWAY |
| Manufacturer City | GALWAY, H91 NHT7 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91 NHT7 |
| Manufacturer Phone | 91774350 |
| Manufacturer G1 | BIO-MEDICAL RESEARCH LTD |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST GALWAY |
| Manufacturer City | GALWAY, H91-NHT7 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91-NHT7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEX BELT |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-22 |
| Returned To Mfg | 2015-11-03 |
| Model Number | 399 |
| Catalog Number | 0390-5060 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-MEDICAL RESEARCH LTD |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY GALWAY, H91-NHT7 EI H91-NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-22 |