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 S7 396 0396-2052 manufactured by Bio-medical Research Ltd.
[36470006]
Consumer reported developing sciatica pain after using the device. Her chiropractor advised she has been treating the consumer since (b)(6) 2015 for an unspecified condition. She also advised the hypertonicity in her right piriformis muscle was evident along with pain in the sciatic nerve and that is was possible the use of the device was causing the buttock muscle to become hypertonic and irritate the surrounding nerves. Testing of the device showed the device was operating as intended and no issue could be found. A review of the device history record for the device showed no major issues during manufacture. Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[36470007]
Consumer reported developing sciatica on her right hand side from mid buttock down her leg. She has been using the unit 3 times a week for 3 weeks, the pain goes away when she stops using the unit. The pain is on one side only.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00028 |
| MDR Report Key | 5382473 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-09-16 |
| Date Mfgr Received | 2016-06-01 |
| Device Manufacturer Date | 2015-04-22 |
| 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 BOTTOM S7 |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-21 |
| Returned To Mfg | 2016-01-06 |
| Model Number | 396 |
| Catalog Number | 0396-2052 |
| 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 |