MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-22 for GUARDIAN G05161 manufactured by Medline Inc.
[37086189]
I was recently prescribed forearm crutches and the vendor issued the medline "guardian" brand forearm crutches. The weight limitations are supposed to be up to (b)(6) support and i weight about (b)(6). While using the crutches to go from my living room to my kitchen, the crutch on my left arm snapped (there is a plastic adjustment bar that slides into a metal crutch) resulting in me falling onto the crutch that fell behind me as it broke where my right hip and upper spine hit not only the crutch, but the floor as well when i fell. I then had to crawl into the next room and be taken by ambulance to the hospital. I have had to have assistance with all activities since and waiting for further testing from my primary care physician to determine extent of injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059764 |
| MDR Report Key | 5398049 |
| Date Received | 2016-01-22 |
| Date of Report | 2016-01-22 |
| Date of Event | 2016-01-20 |
| Date Added to Maude | 2016-01-29 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 | GUARDIAN |
| Generic Name | GUARDIAN |
| Product Code | INP |
| Date Received | 2016-01-22 |
| Model Number | G05161 |
| Lot Number | 40315050025 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Deathisabilit | 2016-01-22 |