MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-22 for SCRAM manufactured by Alcohol Monitoring Services-ams.
[959263]
I wore a scram alcohol monitoring bracelet. The mfr of the device is ams-alcohol monitoring services. When i was wearing the device, i developed severe bone and joint pain. I went to a rheumatologist and he did a bone scan showing abnormalities in all my joints. Within a month of removing the device, the pain subsided. I have not had another bone scan to see if there has been any change in the bone scan. Scram device was worn for 90 days. Dates of use: 2008. Diagnosis or reason for use: alcohol issues. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008736 |
| MDR Report Key | 1210903 |
| Date Received | 2008-10-22 |
| Date of Report | 2008-10-22 |
| Date of Event | 2008-08-30 |
| Date Added to Maude | 2008-11-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCRAM |
| Generic Name | SCRAM |
| Product Code | OIC |
| Date Received | 2008-10-22 |
| Returned To Mfg | 2008-09-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1261303 |
| Manufacturer | ALCOHOL MONITORING SERVICES-AMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-10-22 |