MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-01-21 for SYSTEM ABS 391 manufactured by Bio-medical Research Ltd.
[36468025]
The device was not returned for investigation and no medical report was provided as part of the investigation. Based on the limited information availble, no link could be established between the device and the adverse event reported at this time. Upon retrospective review, this issue was determined to reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[36468026]
Consumer reported hearing a rib snap and felt severe pain as she was increasing the intensity of the device. Consumer stated to bmr that an x-ray completed by her doctor showed a rib was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00012 |
| MDR Report Key | 5382445 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2012-01-27 |
| Date of Event | 2012-01-20 |
| Date Mfgr Received | 2012-01-27 |
| Date Added to Maude | 2016-01-21 |
| 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 | SYSTEM ABS |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-21 |
| Model Number | 391 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-01-21 |