MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-08-31 for ID-MTS READER SA MTS9945 manufactured by Micro Typing Systems Inc.
| Report Number | 1058138-2004-00034 |
| MDR Report Key | 940159 |
| Report Source | 05 |
| Date Received | 2004-08-31 |
| Date of Report | 2004-08-27 |
| Date of Event | 2004-08-12 |
| Date Mfgr Received | 2004-08-12 |
| Device Manufacturer Date | 2001-11-01 |
| Date Added to Maude | 2007-11-13 |
| 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 | 0 |
| Manufacturer Contact | CATHERINE MCMULLEN, SITE DIR. Q/R/C |
| Manufacturer Street | 1295 SW 29TH AVENU7E |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9576239537 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ID-MTS READER SA |
| Generic Name | BLOOD GROUPING CENTRIFUGE AND READER |
| Product Code | KSO |
| Date Received | 2004-08-31 |
| Model Number | MTS9945 |
| Catalog Number | MTS READER SA |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 912457 |
| Manufacturer | MICRO TYPING SYSTEMS INC |
| Manufacturer Address | 1295 SW 29TH AVENUE POMPANO BEACH FL 33069 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-31 |