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 BOTTOM 396 0396-2050 manufactured by Bio-medical Research Ltd.
[36468661]
No medical report was provided for this investigation. Testing was completed on the device and it was found to be operating within specification. A review of the device history records confirms that the device has met its manufacturing specifications. Adverse reactions of skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators. This risk has been documented in the risk assessment and also user instructions for use of the device. ' a small number of isolated skin reactions have been reported by people using muscle stimulation devices, including allergies, a prolonged reddening of the skin and acne'. This complaint has been reported as part of a retrospective review of complaints representing events that are mdr reportable.
Patient Sequence No: 1, Text Type: N, H10
[36468662]
Bio-medical research ltd. Was notified on (b)(6) 2015, via email, of a complaint regarding the slendertone bottom device. A (b)(6) old female customer reported a rash after first using the device in (b)(6) 2014. The rash was located around the upper gel pads area. The customer stopped using the device for a couple of weeks and changed the pads. As soon as the she reused the device, the rash appeared. The customer visited her gp and was given an ointment to use on the areas affected (areas covered by the upper pads and one area under the lower right pad). The customer waited for the rash to disappear and started again in (b)(6) 2015 and the rash reappeared. The customer visited her gp on (b)(6) 2015 and was told to discontinue using the device and was given a cream to use for 2 weeks. The customer has used the ointment for 4 weeks and rash has disappeared.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00027 |
| MDR Report Key | 5382431 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2015-02-27 |
| Date of Event | 2014-11-01 |
| Date Mfgr Received | 2015-04-03 |
| Device Manufacturer Date | 2013-06-18 |
| 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. ANNE-MARIE KEENAN |
| Manufacturer Street | PARKMORE BUSINESS PARK, WEST |
| Manufacturer City | GALWAY, H91 NHT7 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91 NHT7 |
| Manufacturer Phone | 91774316 |
| 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 BOTTOM |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-21 |
| Returned To Mfg | 2015-03-04 |
| Model Number | 396 |
| Catalog Number | 0396-2050 |
| 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, H91 NHT7 EI H91 NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-21 |