MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2016-01-21 for SLENDERTONE FACE 371 0371-2054 manufactured by Bio-medical Research Ltd.
[36464925]
Information was provided to (b)(4) via social media and no customer contact information was provided. The device was not returned for testing and the root cause could not be established. This complaint has been reported as part of a retrospective review of complaints representing events that are mdr reportable.
Patient Sequence No: 1, Text Type: N, H10
[36464926]
(b)(4) was notified on (b)(6) 2014, via email from a trade customer, of a complaint through it's social media. A customer had reported that on use of the slendertone face for 2 -3 weeks, he/she had experienced a broken porcelain crown and a loose bridge. No customer contact details were provided to (b)(4) and no further medical information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00025 |
| MDR Report Key | 5382427 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2016-01-21 |
| Date of Report | 2014-03-19 |
| Date of Event | 2014-03-19 |
| Date Mfgr Received | 2014-03-19 |
| 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 FACE |
| Generic Name | FACIAL STIMULATOR |
| Product Code | NFO |
| Date Received | 2016-01-21 |
| Model Number | 371 |
| Catalog Number | 0371-2054 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-01-21 |