MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-09-07 for CRUTCH AXILLARY TALL 70-78 300LB CA901TL manufactured by Cardinal Health Shanghai.
[54056163]
Without the lot number, the device history report could not be reviewed to determine if there was any exception that could lead to the reported incident. From the review of the production and quality inspection data for the past 12 months, no incident of? Crutch breakage of the hand grip tube area were recorded. The sample was not returned for investigation, however photos of the sample were provided. From the photos of the crutch, the break was confirmed. However, the cause of the breakage could not be derived from the photos. Without the sample we are not able to conduct a further evaluation to determine the actual cause of the broken crutch. Therefore the root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[54056164]
Crutch broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2016-00041 |
| MDR Report Key | 5932419 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-09-07 |
| Date of Report | 2016-09-07 |
| Date of Event | 2016-08-04 |
| Date Facility Aware | 2016-08-09 |
| Date Mfgr Received | 2016-08-09 |
| Date Added to Maude | 2016-09-07 |
| 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 TALL 70-78 300LB |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2016-09-07 |
| Model Number | CA901TL |
| Catalog Number | CA901TL |
| Lot Number | DIDN'T HAVE |
| Operator | LAY USER/PATIENT |
| 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 | 2016-09-07 |