MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-01-21 for SLENDERTONE ABS manufactured by Bio-medical Research Ltd.
[36494591]
The device was not returned for evaluation. No medical report or medical history of the user was provided to the investigation. No causal link between the user and the device can be established. This complaint has been reported as part of a retrospective review of complaints representing events that are mdr reportable. The date of event provided is a best estimate by the manufacturer based on information received.
Patient Sequence No: 1, Text Type: N, H10
[36494592]
Bio-medical research ltd. Was notified by it's distributor of a complaint regarding the system abs (model and serial number unknown). The customer purchased the device in (b)(6) 2011 and had used it for approximately 10 times, at 30-60 minutes per session. The customer has stated that the device felt uncomfortable around the end of (b)(6) of the same year and had consulted with their physician. The customer was subsequently diagnosed with a broken rib and required hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00011 |
| MDR Report Key | 5382718 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2011-12-05 |
| Date of Event | 2011-10-31 |
| Date Mfgr Received | 2011-12-05 |
| 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 ABS |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-21 |
| 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. Hospitalization | 2016-01-21 |