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 SYSTEM ABS 392 (X10) 0392-5014 manufactured by Bio-medical Research.
[32975542]
Root cause not established. Device not returned by the customer - consumer failed to response to 3 attempts to retrieve the device. Device history record was investigated using the serial number and no product issues were noted.
Patient Sequence No: 1, Text Type: N, H10
[32975543]
Consumer felt high discomfort when using the belt and noticed what he believes is an abdominal hernia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00009 |
| MDR Report Key | 5276523 |
| Report Source | CONSUMER |
| Date Received | 2015-12-09 |
| Date of Report | 2014-01-16 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-01-16 |
| Device Manufacturer Date | 2013-01-11 |
| 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 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 | SYSTEM ABS |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2015-12-09 |
| Model Number | 392 (X10) |
| Catalog Number | 0392-5014 |
| 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 |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY GALWAY, H91-NHT7 EI H91-NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-09 |