MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-07 for SHOECOVER DURAFIT UNIV SZ ANTISKID 4852 manufactured by Lianyungang Anson Non-woven Product Co., Ltd.
[116313861]
Based on the supplier? S investigation the device history record could not be reviewed as lot number was not provided. According to the product history record, the cof (coefficient of friction) for this product met specifications. As a sample was not received for further investigation, the root cause of the reported issue could not be determined. The complaint information was provided to the relevant sectors for their awareness. There is no additional action taken at this time, but we will continue to monitor the trend of this type of incident.
Patient Sequence No: 1, Text Type: N, H10
[116313862]
A female staff member (or tech) reportedly slipped and fell while wearing the shoe covers. She went to an orthopedic surgeon and had surgery on her shoulder due to a tear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2018-00231 |
| MDR Report Key | 7759397 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-03-26 |
| Date Facility Aware | 2018-07-13 |
| Date Added to Maude | 2018-08-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOECOVER DURAFIT UNIV SZ ANTISKID |
| Generic Name | COVER, SHOE, OPERATING-ROOM |
| Product Code | FXP |
| Date Received | 2018-08-07 |
| Model Number | 4852 |
| Catalog Number | 4852 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIANYUNGANG ANSON NON-WOVEN PRODUCT CO., LTD |
| Manufacturer Address | NO. 9 HONGKONG RD. GANYU ECONOMIC DEVELOPMENT ZON LIANYUNGANG JIANGSU 222000 CH 222000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-07 |