MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-10-09 for ID-MTS DILUENT 2 * MTS9225 manufactured by Micro Typing Systems, Inc..
[303063]
Customer reported that reagent splashed in eyes while changing dispenser from one empty bottle to a full bottle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056600-2003-00021 |
| MDR Report Key | 488798 |
| Report Source | 06 |
| Date Received | 2003-10-09 |
| Date of Report | 2003-10-08 |
| Date Mfgr Received | 2003-09-30 |
| Date Added to Maude | 2003-10-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CATHERINE MCMULLEN, DIRECTOR |
| Manufacturer Street | 1295 SW 29TH AVE. |
| Manufacturer City | POMPANO, BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239537 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ID-MTS DILUENT 2 |
| Generic Name | LOW IONIC STRENGTH SOLUTION |
| Product Code | KSG |
| Date Received | 2003-10-09 |
| Model Number | * |
| Catalog Number | MTS9225 |
| Lot Number | 002-121 |
| ID Number | * |
| Device Expiration Date | 2004-05-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 477625 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Baseline Brand Name | MTS DILUENT 2 |
| Baseline Generic Name | POTENTIATING MEDIA |
| Baseline Model No | NA |
| Baseline Catalog No | MTS9225 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K920013 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-10-09 |