MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for WARMER DRAPE, SLUSH DRAPES manufactured by Ecolab Inc..
[109631323]
Pt to operating room for surgical procedure. After surgery, during clean-up, it was noted that there was a hole in the warmer drape. Possible contamination issue. Therapy start date: (b)(6) 2018; therapy end date: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077505 |
| MDR Report Key | 7553161 |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-05-21 |
| Date Added to Maude | 2018-05-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | WARMER DRAPE, SLUSH DRAPES |
| Generic Name | WARMER IRRIGATION SOLUTION |
| Product Code | LHC |
| Date Received | 2018-05-29 |
| Lot Number | D180329 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ECOLAB INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-29 |