MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-26 for SHOECOVER ANTI-SKID 2854 manufactured by Lianyungang Anson Non-woven Product Co., Ltd.
[139871884]
A sample for evaluation has been shipped to the manufacturer. The evaluation is still ongoing. A followup mdr will be filed when the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[139871885]
A staff member fell and was injured while wearing the shoe covers. They believe it is because of the shoe covers not having any tread on them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00295 |
| MDR Report Key | 8452503 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-26 |
| Date of Report | 2019-04-09 |
| Date of Event | 2018-12-28 |
| Date Facility Aware | 2019-02-26 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2019-03-26 |
| 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 DR. |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | LIANYUNGANG ANSON NON-WOVEN PRODUCT CO., LTD |
| Manufacturer Street | NO. 9 HONGKONG RD. GANYU ECONOMIC DEVELOPMENT ZON |
| Manufacturer City | LIANYUNGANG JIANGSU 222000 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 222000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOECOVER ANTI-SKID |
| Generic Name | COVER, SHOE, OPERATING-ROOM |
| Product Code | FXP |
| Date Received | 2019-03-26 |
| Returned To Mfg | 2019-03-11 |
| Model Number | 2854 |
| Catalog Number | 2854 |
| Lot Number | 18HDFNA046 |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization | 2019-03-26 |