MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for SAGE PREVALON TAP SYSTEM manufactured by Sag Products Llc.
[139285846]
Through the process of conducting an investigation related to an adverse event, it has been noted that the sage prevalon tap system 2. 0 is not compatible to be used in conjunction with the standard operating room wedge that is often used by anesthesia when pts are not able to tolerate lying flat. When the mat and the positioning wedge are placed against each other, they become extremely slippery and can lead to pt falls in the operating room. Cross-check of mfr recommendations do not alert users to this potential hazard as they, sage may not be aware. It is important to note that while this product was a contributing factor to the event it was not the direct cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8433441 |
| MDR Report Key | 8433441 |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-07 |
| Date of Event | 2018-12-19 |
| Date Facility Aware | 2018-12-19 |
| Report Date | 2019-03-07 |
| Date Reported to FDA | 2019-03-07 |
| Date Reported to Mfgr | 2019-03-07 |
| Date Added to Maude | 2019-03-19 |
| 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 | SAGE PREVALON TAP SYSTEM |
| Generic Name | PREVALON TAP SYSTEM 2.0 |
| Product Code | KME |
| Date Received | 2019-03-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAG PRODUCTS LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2019-03-12 |