MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-05 for ECOLAB/MICROTEK MEDICAL ORS-320N manufactured by Ecolab.
[101842125]
Avid medical issued formal complaint #(b)(4) to the manufacturer ecolab/microtek medical concerning the warmer drape leaking during the procedure for item no. Ors-320n, manufacturer lot# d170801. The affected device was not available for evaluation per end-user.
Patient Sequence No: 1, Text Type: N, H10
[101842126]
Avid medical is the manufacturer of a custom procedure tray that includes the following component: drape slush warmer disc 44x66, vendor part # ors-320n manufactured by ecolab/microtek medical. Avid medical received a complaint on (b)(6) 2018 originated by (b)(6), material, (b)(6) stating that "it was noticed that the warming drape had leaked into the basin during procedure. " the affected drape was not available for evaluation. Avid medical issued formal complaint #(b)(4) to the manufacturer ecolab/microtek medical concerning the warmer drape leaking during the procedure for item no. Ors-320n, manufacturer lot# d170801. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1047429-2018-00001 |
| MDR Report Key | 7313167 |
| Date Received | 2018-03-05 |
| Date of Report | 2018-03-05 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-02-05 |
| Date Added to Maude | 2018-03-05 |
| 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 | 3 |
| Manufacturer Contact | SHARON MOLL |
| Manufacturer Street | 9000 WESTMONT DR. |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal | 23168 |
| Manufacturer Phone | 7575663510 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ECOLAB/MICROTEK MEDICAL |
| Generic Name | IRRIGATION SOLUTION WARMER |
| Product Code | LHC |
| Date Received | 2018-03-05 |
| Model Number | ORS-320N |
| Lot Number | D170801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ECOLAB |
| Manufacturer Address | 370 N. WABASHA STREET ST. PAUL MN 55102 US 55102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-05 |