MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-15 for WANDER GUARD manufactured by Wanderguard, Inc..
[9847]
The facility has door monitors in place on all doors going out of facility. They have had a problem with the monitors going off every time the doors are opened by people not wearing wrist signal devices. This results in the monitors having to be shut down. On the date of incident, the resident left the facility during an episode of this nature. Fortunately, he was detected going down the street and returned safely by staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003378 |
| MDR Report Key | 16165 |
| Date Received | 1994-09-15 |
| Date of Report | 1994-08-26 |
| Date of Event | 1994-08-23 |
| Date Added to Maude | 1994-09-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WANDER GUARD |
| Generic Name | DOOR EXIT MONITOR DEVICE |
| Product Code | GYE |
| Date Received | 1994-09-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16098 |
| Manufacturer | WANDERGUARD, INC. |
| Manufacturer Address | LINCOLN NE 68508 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-09-15 |