MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-03-24 for SHOECOVER DURA FIT XL 200/PR 4854 manufactured by Cardinal Health Singapore 225 Pte Ltd.
[15314165]
Customer reported that the shoe covers were slippery and that a nurse fell and hit the floor.
Patient Sequence No: 1, Text Type: D, B5
[15670630]
The customer has not yet provided the samples or information regarding the nurse? S age, weight and gender. The customer apparently had six lot numbers in stock (14lef325, 14gef205, 14lef316, 14mef350, 14kef291, and 14kef227). They remove the shoe covers from their boxes and store them in a bin, so it appears that the actual lot# involved is difficult to identify. This complaint has been forwarded to the plant for investigation. A follow up report will be filed once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[24224046]
The customer did not provide any additional information about the nurse; and they did not provide samples. One of the reported lot#s, 14kef227, could not be verified as there was no record of the reported lot# in the dhr. The remaining lot#s reported by the customer had been reviewed and found to be made across a span of 5 months from 08/2014 to 12/2014. No exception was recorded in the dhr's for these lots that could lead to the reported incident. Historical trending was done. A review of the dhr showed that the products had been manufactured according to sop requirements and the measured coefficient of friction (cof) was meeting the specification. Reserved samples from these lots had also been subjected to the cof test and confirmed to be meeting specification. The root cause could not be determined. The relevant sectors were informed of the complaint. There is no additional action taken at this time, but we will continue to monitor for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
[24379028]
Samples were received on 04/27/2015, therefore this is being filed as the 2nd follow up report. Visually, the anti-slip strips on the returned shoe covers were found complete and clearly visible. The sewing line was located in the middle of the sole, and the anti-skid was evenly distributed on both sides. The position of the print and anti-skid were all within specification. The measurement of the critical dimensions indicated that all the dimensions met the desired specification. Coefficient of friction (cof) test result also confirmed that the shoe covers were performing above the cof specification of (b)(4). The root cause could not be determined from this investigation. The relevant sectors were informed of the complaint. There is no additional action taken at this time, but we will continue to monitor complaints for trends of this nature
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2015-00014 |
| MDR Report Key | 4628478 |
| Report Source | 05,07 |
| Date Received | 2015-03-24 |
| Date of Report | 2015-05-18 |
| Date of Event | 2015-02-23 |
| Date Mfgr Received | 2015-02-23 |
| Date Added to Maude | 2015-03-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH SINGAPORE 225 PTE LTD |
| Manufacturer Street | 10 KALLANG AVENUE |
| Manufacturer City | SINGAPORE 339510 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 339510 |
| 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 | 2015-03-24 |
| Returned To Mfg | 2015-04-27 |
| Catalog Number | 4854 |
| Lot Number | SEE SECTION H10 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH SINGAPORE 225 PTE LTD |
| Manufacturer Address | 10 KALLANG AVENUE SINGAPORE 339510 SN 339510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-24 |