MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for ECOLAB ORS 100 FLUID WARMER DRAPE ORS100 manufactured by Ecolab.
[138531901]
Patient was having a creation of an ostomy procedure. There was a sterile warmer drape used throughout the entire case. After the procedure, staff were cleaning the operating room surgery room and noted that upon lifting the warmer drape up, there was a small hole in the bottom of the drape. There was no saline in the warmer, only when the warmer drape was lifted up was the small hole noted. Warmer was used to irrigate and for warm laps/raytec. No injury noted. Scrub rn reported no leakage of fluid through the drape although a hole was visible after removing the drape. Heating element was full. The fluid was not used until after the wound closure, just to clean the patient's skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8412038 |
| MDR Report Key | 8412038 |
| Date Received | 2019-03-12 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-12-10 |
| Report Date | 2019-03-05 |
| Date Reported to FDA | 2019-03-05 |
| Date Reported to Mfgr | 2019-03-12 |
| Date Added to Maude | 2019-03-12 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | ECOLAB ORS 100 FLUID WARMER DRAPE |
| Generic Name | DRAPE, SURGICAL |
| Product Code | KKX |
| Date Received | 2019-03-12 |
| Catalog Number | ORS100 |
| Lot Number | 361374 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ECOLAB |
| Manufacturer Address | 1 ECOLAB PLACE SAINT PAUL MN 55102 US 55102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-12 |