MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-01-21 for SLENDERTONE ABS 399 0399-2052 manufactured by Bio-medical Research Ltd.
[36470120]
Consumer did not provide a medical report. Evaluation of the device showed no issue with the device. Device history records showed no major issues within the batch. No link has been established at this time between the use of the device and the adverse event reported. Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[36470121]
Event was reported by consumers daughter on behalf of her mother. The consumer claimed after using the device 4 times, she suffered chest pains and was taken to hospital. At the hospital she was told of possible muscle and nerve damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00020 |
| MDR Report Key | 5382468 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2013-04-17 |
| Date of Event | 2013-04-11 |
| Date Mfgr Received | 2013-04-17 |
| Device Manufacturer Date | 2012-12-07 |
| 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 | SLENDERTONE ABS |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-21 |
| Returned To Mfg | 2013-09-09 |
| Model Number | 399 |
| Catalog Number | 0399-2052 |
| 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 | 2016-01-21 |