MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-01 for ECO LAB MICROTEK MEDICAL INC. manufactured by Eco Lab / Microtek Medical Inc..
[126216892]
Warmer drape used for irrigation fluid. At end of case when drape removed, discovered fluid in the warmer pan. The warmer drape had a hole and there was communication between the unsterile metal receptacle and the irrigation fluid. The product is not compounded; the product is not over-the-counter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081015 |
| MDR Report Key | 8032940 |
| Date Received | 2018-11-01 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-09-27 |
| Date Added to Maude | 2018-11-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ECO LAB MICROTEK MEDICAL INC. |
| Generic Name | ECO LAB, MICROTEK MEDICAL INC, WARMER, IRRIGATION, SOLUTION |
| Product Code | LHC |
| Date Received | 2018-11-01 |
| Returned To Mfg | 2018-10-01 |
| Lot Number | D180969 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ECO LAB / MICROTEK MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-01 |