MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-26 for STEERABLE KNEE WALKER CWAL240KSR manufactured by Cardinal Health Shanghai.
[189051327]
The complaint was forwarded to the manufacturing facility where it is currently still under investigation. A follow-up report will be filed once the results have been completed.
Patient Sequence No: 1, Text Type: N, H10
[189051328]
The customer previously had a reconstructive foot surgery for arch and heel requiring use of a steerable knee walker. This customer stated that the steerable knee walker cwal240ksr, lot 8400009636-sh-1902 had a defected steering handle and faulty brakes that allegedly caused him to be lodged off the walker three times. The pharmacy provided a second knee walker that the customer reported had a seat that was rippling and cracking where the knee rests and now he allegedly has inflammation in his right knee. A follow-up x-ray showed the arch is not healing correctly and the customer is concerned the altered healing is secondary to the defective knee walker. He reportedly complains of continued pain spikes from nerves, muscle tissue & bone tenderness where he was prescribed oxycodone 10mg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00388 |
| MDR Report Key | 9522107 |
| Date Received | 2019-12-26 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-11-25 |
| Date Facility Aware | 2019-11-25 |
| Date Mfgr Received | 2019-11-25 |
| Date Added to Maude | 2019-12-26 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEERABLE KNEE WALKER |
| Generic Name | WALKER, MECHANICAL |
| Product Code | ITJ |
| Date Received | 2019-12-26 |
| Model Number | CWAL240KSR |
| Catalog Number | CWAL240KSR |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-12-26 |