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 FACE 372 0372-2052 manufactured by Bio-medical Research Ltd.
[36527994]
Consumer did not provide a medical report / evaluation. Device was returned for evaluation and passed testing as per the test requirements. Consumer suffered a known adverse skin reaction and this is documented in our user manuals for the use of the device. Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[36527995]
Consumer reported after using her product for 20 minutes, swelling started underneath the paddles of the unit and behind her ears. She took an antihistamine and the swelling gradually went down. The consumer suffers from underactive thyroid but has been using other slendertone product for years without any issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00023 |
| MDR Report Key | 5383264 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2014-02-03 |
| Date of Event | 2014-02-02 |
| Date Mfgr Received | 2014-02-03 |
| 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 FACE |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-21 |
| Returned To Mfg | 2014-05-23 |
| Model Number | 372 |
| Catalog Number | 0372-2052 |
| 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 |