MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-01-21 for SLENDERTONE ABS MALE 392 0392-1000 manufactured by Bio-medical Research Ltd.
[36469537]
The device was not returned for evaluation and without a serial number no review of the device history record could be completed. Consumer provided letter from his doctors stating he was suffering from diastasis recti abdominis but did not confirm this was caused by the slendertone device. Consumer advised he had purchased the product 9 years previous and had been using it for a long period of time. At this time, no link has been established between the adverse event and the use of the slendertone device. Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[36469538]
Consumer advised he is suffering from a lump poking through his ribs. He is a pe teacher and is unable to exercise his abdominals and this is affecting his job.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00019 |
| MDR Report Key | 5382465 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-01-21 |
| Date of Report | 2013-04-15 |
| Date of Event | 2013-04-15 |
| Date Mfgr Received | 2013-04-15 |
| 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 MALE |
| Generic Name | POWERED MUSCLLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-21 |
| Model Number | 392 |
| Catalog Number | 0392-1000 |
| 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 |