MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-10-14 for QUICK CHANGE CRUTCH ADULT 9153618192 8115-A manufactured by Healthplus.
[5088109]
End user's wife advised husband was walking on replacement crutches and noticed the plastic piece that holds the adjust bar had slipped down. Husband was walking down the sidewalk in front of the house and fell on the sidewalk, no apparent injuries, no medical attention sought. End user is a recent amputee and goes to physical therapy and makes them aware when he falls, they are not sure of model number but thinks it is adjust.
Patient Sequence No: 1, Text Type: D, B5
[5203557]
End user's wife advised husband was walking on replacement crutches and noticed the plastic piece that holds the adjust bar had slipped down. Husband was walking down the sidewalk in front of the house and fell on the sidewalk, no apparent injuries, no medical attention sought. End user is a recent amputee & goes to physical therapy and makes them aware when he falls, they are not sure of model number but thinks it is adjust.
Patient Sequence No: 1, Text Type: D, B5
[12626599]
(b)(4) 2014 -- initial mfg report # 1525712-2014-06968 was submitted to the fda on 10/14/2014 as a manufacturer. With the knowledge of the actual manufacturer, this is now an importer report, not a manufacturer, therefore, the correct fda (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525712-2014-06968 |
| MDR Report Key | 4169753 |
| Report Source | 04 |
| Date Received | 2014-10-14 |
| Date of Report | 2014-09-25 |
| Date of Event | 2014-09-10 |
| Date Mfgr Received | 2014-09-25 |
| Date Added to Maude | 2014-10-27 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN GUYTON |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | UNKNOWN |
| Manufacturer City | OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICK CHANGE CRUTCH ADULT 9153618192 |
| Generic Name | TIPS AND PADS, CANE, CRUTCH AND WALKE |
| Product Code | IPR |
| Date Received | 2014-10-14 |
| Model Number | 8115-A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALTHPLUS |
| Manufacturer Address | HANDAN OH CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-14 |