MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-09 for MEDLINE GUARDIAN BARIATRIC HEAVY DUTY PUSH BUTTON CRUTCHES * MDS80335XW manufactured by A & I Industries Ltd.
[5932547]
Crutches came in with a substance that looked like tiny balls of metal inside the sealed package. ======================manufacturer response for heavy duty push button crutches, guardian (per site reporter). ======================i contacted the distributor. That is where we get the crutches from. They are sending me shipping material to send the crutches back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4837584 |
| MDR Report Key | 4837584 |
| Date Received | 2015-06-09 |
| Date of Report | 2015-06-09 |
| Date of Event | 2015-06-09 |
| Report Date | 2015-06-09 |
| Date Reported to FDA | 2015-06-09 |
| Date Reported to Mfgr | 2015-06-11 |
| Date Added to Maude | 2015-06-11 |
| 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 | MEDLINE GUARDIAN BARIATRIC HEAVY DUTY PUSH BUTTON CRUTCHES |
| Generic Name | CRUTCHES |
| Product Code | INP |
| Date Received | 2015-06-09 |
| Model Number | * |
| Catalog Number | MDS80335XW |
| Lot Number | 40315010001 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A & I INDUSTRIES LTD |
| Manufacturer Address | 33 GOLDEN EAGLE LANE LITTLETON CO 80127 US 80127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-09 |