MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-11 for STANLEY HEALTHCARE 73030 manufactured by Stanley Healthcare.
| Report Number | 8691211 |
| MDR Report Key | 8691211 |
| Date Received | 2019-06-11 |
| Date of Report | 2018-04-04 |
| Date of Event | 2018-03-29 |
| Date Facility Aware | 2018-03-29 |
| Report Date | 2018-04-04 |
| Date Reported to FDA | 2018-04-04 |
| Date Reported to Mfgr | 2018-04-04 |
| Date Added to Maude | 2019-06-12 |
| 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 | 0 |
| Brand Name | STANLEY HEALTHCARE |
| Generic Name | CHAIR SENSORMAT PAD |
| Product Code | KMI |
| Date Received | 2019-06-11 |
| Model Number | 73030 |
| Lot Number | AG0617 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY HEALTHCARE |
| Manufacturer Address | WALTHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2019-06-11 |