MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-19 for CRUTCHES MDSV80535 * manufactured by Medline Industries, Inc..
[5594819]
The therapist was in front of the patient and the assistant in the back of the patient. Patient was using the rail and a crutch on the steps, coming down, and the crutch came apart. The top rubber and aluminum separated from the whole crutch. The crutches were new and had just been opened in the morning pt visit and were just fine at the time. The patient's weight was less than 100 lbs. The rehab assistant who completed this report has been here for several years. ======================manufacturer response for aluminum crutch, medline (per site reporter). ======================i talked to quality and said i had the crutch to send back. They asked me to send a picture and i told him i wanted to send the actual crutch for investigation. They are sending me a shipping label.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4634683 |
| MDR Report Key | 4634683 |
| Date Received | 2015-02-19 |
| Date of Report | 2015-02-19 |
| Date of Event | 2015-02-17 |
| Report Date | 2015-02-19 |
| Date Reported to FDA | 2015-02-19 |
| Date Reported to Mfgr | 2015-03-26 |
| Date Added to Maude | 2015-03-26 |
| 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 | CRUTCHES |
| Generic Name | TIPS AND PADS, CANE, CRUTCH AND WALKER |
| Product Code | INP |
| Date Received | 2015-02-19 |
| Model Number | MDSV80535 |
| Catalog Number | * |
| Lot Number | 140866702 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-19 |