MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-29 for N/A manufactured by Unknown.
[93189070]
Patient Sequence No: 1, Text Type: N, H10
[93189071]
Fluid warmer drape used during the surgical procedure was seeping through the drape. Fluid noted in the fluid warmer equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7066623 |
| MDR Report Key | 7066623 |
| Date Received | 2017-11-29 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-11-06 |
| Report Date | 2017-11-21 |
| Date Reported to FDA | 2017-11-21 |
| Date Reported to Mfgr | 2017-11-21 |
| Date Added to Maude | 2017-11-29 |
| 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 |
| 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 | N/A |
| Generic Name | WARMER, IRRIGATION SOLUTION |
| Product Code | LHC |
| Date Received | 2017-11-29 |
| Lot Number | 17IK0489 |
| ID Number | DYNJ52564A |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-29 |