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 398 0398-2052 manufactured by Bio-medical Research Ltd.
[36526168]
Returned device passed testing as per test requirements. Review of device history records at supplier site showed no major issues in the manufacturing process for that batch. No medical report was supplied by the consumer. Instruction manual dos and donts section indicates 'a small number of isolated skin reactions have been reported by people using muscle stimulation devices.... '. Based on the limited information to hand, it appears the consumer may have suffered a known adverse reaction. Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[36526169]
Consumer used the abs belt 3 times and noticed itchy spots under the pads. After 3 weeks the spots turned brown and began to go away. Her doctor prescribed aqueous cream and ointment which did not help and so then prescribed steroids, antibiotic and piriton.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00018 |
| MDR Report Key | 5383256 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2013-02-25 |
| Date of Event | 2013-01-24 |
| Date Mfgr Received | 2013-02-25 |
| Device Manufacturer Date | 2012-09-21 |
| 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 | 2013-05-01 |
| 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 WEST GALWAY GALWAY, H91-NHT7 EI H91-NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-21 |