MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2012-05-10 for PRINTER, THERMAL, 110V 11-781 manufactured by Alere San Diego Inc.
[2718938]
Customer alleged an ldx printer began smoking and was printing all black labels when they tried to use it. No report of death or serious injury.
Patient Sequence No: 1, Text Type: D, B5
[9928185]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2012-00689 |
| MDR Report Key | 2579640 |
| Report Source | 00,05 |
| Date Received | 2012-05-10 |
| Date of Report | 2012-05-10 |
| Date of Event | 2012-04-11 |
| Date Mfgr Received | 2012-04-11 |
| Date Added to Maude | 2012-09-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMEN BERGELIN, MGR |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRINTER, THERMAL, 110V |
| Generic Name | CHOLESTEROL METER |
| Product Code | CHH |
| Date Received | 2012-05-10 |
| Returned To Mfg | 2012-05-02 |
| Model Number | 11-781 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO INC |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-10 |