MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-01 for GUARDIAN SIGNATURE * G30757W manufactured by Medline Industries, Inc.
[5768361]
Patient was impulsive and needed to use the bathroom. Patient was assisted by two rns from the chair near the bathroom to the bathroom with the use of a walker, front wheeled. Patient was confused and did have trouble with his gait. Patient leaned forward with walker as he was walking to the bathroom and the front wheel of the walker broke completely off. Patient lost balance and fell forward as rn caught him and, with help of the second rn, lowered the patient to his knees. A third rn helped lift the patient to his feet. No complications noted through frequent neuro and vitals. Patient denied pain. Md was notified and no further testing or interventions were indicated. This is from the patient safety report: pt got up out of chair with assistance from two rns. Pt leaned forward and the walker broke. Pt was assisted down to one knee by both rns. No complications were noted. This is the walker serial #: (b)(4). ======================manufacturer response for walker, guardian, w/5in wheel, adult (per site reporter). ======================i have already received a replacement and i have requested a follow up investigation letter. I will forward that to you when i get it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4741781 |
| MDR Report Key | 4741781 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-04-01 |
| Date of Event | 2015-03-25 |
| Report Date | 2015-04-01 |
| Date Reported to FDA | 2015-04-01 |
| Date Reported to Mfgr | 2015-05-01 |
| Date Added to Maude | 2015-05-01 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUARDIAN SIGNATURE |
| Generic Name | TIPS AND PADS, CANE, CRUTCH AND WALKER |
| Product Code | INP |
| Date Received | 2015-04-01 |
| Returned To Mfg | 2015-03-30 |
| Model Number | * |
| Catalog Number | G30757W |
| Lot Number | M121117174 |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | R |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC |
| Manufacturer Address | 33 GOLDEN EAGLE LANE LITTLETON CO 80127 US 80127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-04-01 |