MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2011-09-28 for SHOECOVER DURA FIT XL 200/PR 4874 manufactured by Cardinal Health.
[2304686]
Surgical technologist was walking down the hall when he apparently slipped and fell. He went to the emergency room, and currently is under the care of an orthopedic specialist. The employee is unable to work at this time. It was reported that no water/fluid spill was present.
Patient Sequence No: 1, Text Type: D, B5
[9326266]
The customer was not able to provide the lot number, therefore, the device history record could not be reviewed. Historical trending was done. A review of the test results for the force profile, measured for the returned sample, indicates that the skid resistance is consistent with similar measurements performed on shoe covers in the past. From the test result, the performance of the returned sample was confirmed to be consistent with the expected performance of current shoe covers, and no abnormality was identified. The root cause of the failure could not be determined from this investigation. We will continue to monitor complaints for any trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2011-00075 |
| MDR Report Key | 2267872 |
| Report Source | 04,05,07 |
| Date Received | 2011-09-28 |
| Date of Report | 2011-09-28 |
| Date of Event | 2011-09-01 |
| Date Mfgr Received | 2011-09-01 |
| Date Added to Maude | 2011-09-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH 200, LLC |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOECOVER DURA FIT XL 200/PR |
| Generic Name | COVER, SHOE, OPERATING ROOM |
| Product Code | FXP |
| Date Received | 2011-09-28 |
| Returned To Mfg | 2011-09-15 |
| Catalog Number | 4874 |
| Lot Number | NO LOT GIVEN |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-28 |