MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-09 for SLENDERTONE ULTRA 0517 0517-5000 manufactured by Bio-medical Research Ltd..
[32975639]
No action taken as customer did not return product for investigation and on 11. 11. 14 the customer requested that we close out the complaint. Note no medical report or other evidence was supplied by the customer. The slendertone ultra ifu provides the following information contact slendertone if: you experience any irritation, skin reaction, hypersensitivity, or other adverse reaction.
Patient Sequence No: 1, Text Type: N, H10
[32975640]
The customer experienced discomfort and sores/puss from sores on skin. The customer went to doctor and was told that he was allergic to gel pads. The customer has not used the belt since.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00005 |
| MDR Report Key | 5276521 |
| Report Source | CONSUMER |
| Date Received | 2015-12-09 |
| Date of Report | 2014-08-29 |
| Date of Event | 2014-08-29 |
| Date Mfgr Received | 2014-08-29 |
| Device Manufacturer Date | 2013-07-19 |
| Date Added to Maude | 2015-12-09 |
| 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 ULTRA |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2015-12-09 |
| Model Number | 0517 |
| Catalog Number | 0517-5000 |
| 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, H91 NHT7 EI H91 NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-09 |