MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-10-23 for MTS DISPENSER 1.0MI MTS9612 manufactured by Micro Typing Systems, Inc..
[575488]
The customer reported that the mts dispenser was not holding fluid. If there is an incorrect or no dispense event that goes undetected, erroneous results could be reported. There was no report of harm as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[7821732]
Investigation into this event showed that the customer discarded the instrument before evaluation was conducted. Therefore, no analysis was possible, and root cause was unable to be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2006-00217 |
| MDR Report Key | 830134 |
| Report Source | 05,06 |
| Date Received | 2006-10-23 |
| Date of Report | 2006-10-23 |
| Date of Event | 2004-10-08 |
| Date Mfgr Received | 2004-10-08 |
| Date Added to Maude | 2007-03-23 |
| 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 | DAVID HAGEN, SITE MANAGER |
| Manufacturer Street | 1295 SW 29TH AVENUE |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239528 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTS DISPENSER 1.0MI |
| Generic Name | DISPENSER |
| Product Code | GJG |
| Date Received | 2006-10-23 |
| Model Number | NA |
| Catalog Number | MTS9612 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 817522 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Baseline Brand Name | MTS DISPENSE 1.0ML |
| Baseline Generic Name | MTS DISPENSER 1.0ML |
| Baseline Model No | MTS9612 |
| Baseline Catalog No | MTS DISPENSER |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-23 |