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 S7 398 0398-2052 manufactured by Bio-medical Research Ltd..
[36468291]
The device (serial number (b)(4)) was tested and found to be operating within expected output parameter ranges. The device history record was reviewed and the device has been confirmed to have met it's specifications. On review of the medical report supplied to the manufacturer, pre-existing medical conditions of bulimia and stress factors were detailed. At this time, no link has been established between the adverse event and the use of the slendertone device.
Patient Sequence No: 1, Text Type: N, H10
[36468292]
Bio-medical research ltd. Was notified on june 10, 2015 via email by it's call centre that they had received a complaint regarding the slendertone abs (part number 0390-2008). The female customer had purchased the device on (b)(6) 2015. The customer had reported on using the device 4 times, she encountered issues with her heartbeat (rapid heartbeat). She was in hospital for 3 days and received a full check-up. During her hospitalization, her condition was reviewed and the patient was diagnosed as having dyspnea with heart palpitations and chest pains. The patient recovered but was advised against future use of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00029 |
| MDR Report Key | 5382408 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-06-07 |
| Date Mfgr Received | 2015-06-10 |
| Device Manufacturer Date | 2015-01-01 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ANNE-MARIE KEENAN |
| Manufacturer Street | PARKMORE BUSINESS PARK |
| Manufacturer City | GALWAY, H91 NHT7 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91 NHT7 |
| Manufacturer Phone | 91 774316 |
| Manufacturer G1 | BIO-MEDICAL RESEARCH LTD |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| 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 S7 |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-21 |
| Returned To Mfg | 2015-06-22 |
| Model Number | 398 |
| Catalog Number | 0398-2052 |
| 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 GALWAY, H91 NHT7 EI H91 NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-01-21 |