MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-12-08 for CRUTCH AXILLARY YOUTH 52-62 300LB CA901YTH manufactured by Cardinal Health Shanghai.
[61729792]
A sample was not returned for investigation; therefore we are unable to determine the exact cause for the issue reported. Photos were provided that show that the crutch did break as reported, therefore confirming the issue reported, but we are unable to confirm the cause for the break. Sample of the failed device has been requested from the end user, but as of now has not been returned from the end user. If the sample is returned the investigation will be reopened. A review of the device history record for lot number 8400005271-sh showed no exceptions recorded that would have led to the reported incident. The supplier (b)(4) checked? The (b)(4) materials and processing process as well as the assembly process and assembly workshop and no issues were found that would have contributed to the issue reported. We will continue to monitor for any similar reports.
Patient Sequence No: 1, Text Type: N, H10
[61729793]
Based on the customer? S husbands statement, the metal where the height is adjusted on the crutch split causing his wife to fall. ? He stated she only uses them when she transitions from a knee walker to a recliner and she only takes two "baby steps. " when the crutch split she fell forward and hit her head on a dresser that is in the room and split her head open.? Emt? S were called and she was transported to (b)(6) hospital. She suffered a mild neck sprain, banged her bad foot on the floor and received six stitches for the wound on her head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2016-00062 |
| MDR Report Key | 6154560 |
| Report Source | CONSUMER |
| Date Received | 2016-12-08 |
| Date of Report | 2016-12-08 |
| Date of Event | 2016-11-06 |
| Date Facility Aware | 2016-11-10 |
| Report Date | 2016-12-08 |
| Date Reported to FDA | 2016-12-08 |
| Date Reported to Mfgr | 2016-11-10 |
| Date Mfgr Received | 2016-11-10 |
| Date Added to Maude | 2016-12-08 |
| 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 | 3 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer G1 | CARDINAL HEALTH SHANGHAI |
| Manufacturer Street | F20, TOWER 1, KERRY EVERBRIGHT |
| Manufacturer City | SHANGHAI 200070 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 200070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRUTCH AXILLARY YOUTH 52-62 300LB |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2016-12-08 |
| Model Number | CA901YTH |
| Catalog Number | CA901YTH |
| Lot Number | 8400005271SH |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH SHANGHAI |
| Manufacturer Address | F20, TOWER 1, KERRY EVERBRIGHT SHANGHAI 200070 CH 200070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-08 |