MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2016-01-21 for THE FLEX BELT 399 0399-5060 manufactured by Bio-medical Research Ltd.
[36493734]
Root cause of the complaint could not be established. No independent medical record or completed manufacturer medical questionnaire were provided to bio-medical research ltd as part of the investigation into the complaint. On review of the complaint, the senior clinical scientist (bio-medical research ltd. ) advised that the user may have an underlying hernia or weakness with the abdominal wall prior to use. The device was tested and found to be operating within specification, however, the device usage history showed that no sessions had been performed using this device. Note: date of event is best estimate based on information received by bio-medical research ltd.
Patient Sequence No: 1, Text Type: N, H10
[36493735]
Bio-medical research ltd. Was notified on (b)(6) 2015 of a complaint regarding the flex belt (part number 0399-5060). A female customer had reported that the belt felt uncomfortable and that it appeared that her navel had moved. Her doctor has diagnosed a hernia. No medical report has been supplied to bio-medical research ltd.. The customer had previously used the belt up to 3 times per day for short periods. The customer had last used the belt approximately 4 months ago and cannot use the belt now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00022 |
| MDR Report Key | 5382732 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2016-01-21 |
| Date of Report | 2015-11-24 |
| Date of Event | 2015-11-01 |
| Date Mfgr Received | 2015-11-23 |
| Device Manufacturer Date | 2015-07-13 |
| 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 | THE FLEX BELT |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-21 |
| Returned To Mfg | 2016-01-02 |
| Model Number | 399 |
| Catalog Number | 0399-5060 |
| 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, H91 NHT7 EI H91 NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-21 |