MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-19 for WALKER, RIGID, NON FOLDING MDS86204 * manufactured by Medline Industries, Inc..
[20156377]
Report received that while the walker was being used by a patient, it broke at the cross brace attached to the right rear leg at the bolt area. The patient fell and received several skin tears to her arms. No other injury was reported. The report source states the walker was provided to the patient the day before the event. She had been instructed in proper use by a physical therapist. The walker had front wheel and rear glider extensions applied. No additional information was available.
Patient Sequence No: 1, Text Type: D, B5
[20446288]
The walker was received with guardian wheel extensions on the front legs, and an unidentified manufacturer's extensions on the back legs. The walker has a broken right rear leg at the rivet which joins the cross frame and the rear leg. The hardness and thickness of the broken leg both measured within product specification. The stability of the walker as received with the non-medline front and rear leg extensions was evaluated. The broken right rear leg was put back into place in a vertical position. The diagonal measurement between the left rear leg and right front leg is 28. 5 inches. The diagonal measurement between the right rear leg and left front leg is 27 inches. When measuring the same diagonal length with this style of walker and similar medline extensions, the legs are equally spaced at 28. 75 inches. It is critical for the walker to have an approximately square template to be stable. If this square is not equally spaced, force is not applied/dispersed evenly across the four legs of the walker. The instruction booklet that ships with the walker has an "important precautions" area which includes the following statement: "use medline accessories only. Use of other accessories may result in improper fit and risk of fall and injury. " the reason for the precaution is that medline walkers have had extensive testing with medline accessories to ensure that the square template, and thus walker stability, is maintained when accessories are applied to the walker. This ensures an even distribution of force applied to all for legs when the walker is used appropriately. Additionally, the guardian label on the front leg extensions states: "use only on guardian walkers. " for additional evaluation, a walker sample was randomly selected from inventory for comparison and static loading testing. The sample was tested at an inclination of 18 degrees with a vertical force applied on the two hand grips. The unit sustained 1765 lbs of force without any deformation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2007-00010 |
| MDR Report Key | 836895 |
| Report Source | 05 |
| Date Received | 2007-02-19 |
| Date of Report | 2007-01-26 |
| Date of Event | 2007-01-26 |
| Date Mfgr Received | 2007-01-26 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2007-04-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKER, RIGID, NON FOLDING |
| Generic Name | WALKER |
| Product Code | NXE |
| Date Received | 2007-02-19 |
| Returned To Mfg | 2007-02-12 |
| Model Number | MDS86204 |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 824198 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | * MUNDELEIN IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-19 |