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 517 0517-5006 manufactured by Bio-medical Research Ltd..
[32976055]
The root cause was not established as the customer did not return the device after 5 contact attempts by manufacturer. Device was not returned for evaluation and no medical report was made available for review.
Patient Sequence No: 1, Text Type: N, H10
[32976056]
Customer reported that she suffered uterine bleeding after using the ultra belt twice (over a period of two days), she then stopped using it (for one day) and the bleeding stopped. She then used it again and on the same day the bleeding started again. The patient then consulted her gynaecologist who examined her and told her there was no underlying reason for the bleeding (she could find nothing wrong) and she was advised to stop using the belt. Since she stopped using the belt there has been no bleeding
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00004 |
| MDR Report Key | 5276509 |
| Report Source | CONSUMER |
| Date Received | 2015-12-09 |
| Date of Report | 2015-11-24 |
| Date of Event | 2015-01-19 |
| Date Mfgr Received | 2015-01-19 |
| Device Manufacturer Date | 2014-08-29 |
| 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 | 517 |
| Catalog Number | 0517-5006 |
| 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 |