MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-25 for COVERALLS ELASTIC CUFF & ANKLE 2XL WHT 2202CV manufactured by Jiangsu Wonderful Nonwoven Tech. Co., Ltd.
[143217226]
Based on the supplier investigation the device history record review did not indicate any exception that could lead to the reported incident. No sample was available for investigation. According to the supplier, the finished products meet the requirements of cardinal health and all inspections are within specification limits. Test results of the (b)(6) meet the specification requirements and no deviation was found during the manufacturing process. From the investigation, the root cause for the reported incident could not be determined. At this time no additional action will be taken but we will continue to monitor the trend of this type of incident.
Patient Sequence No: 1, Text Type: N, H10
[143217227]
An employee reported an allergic reaction to the exterior of the white coveralls. She was sent to her allergy md on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00312 |
| MDR Report Key | 8552034 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-04-08 |
| Date Facility Aware | 2019-04-08 |
| Report Date | 2019-04-09 |
| Date Reported to Mfgr | 2019-04-09 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-04-25 |
| 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 | JIANGSU WONDERFUL NONWOVEN TECH. CO., LTD |
| Manufacturer Street | 302 BEIJING EAST RD, SIYANG |
| Manufacturer City | SUQIAN CITY JIANGSU 223700 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 223700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COVERALLS ELASTIC CUFF & ANKLE 2XL WHT |
| Generic Name | NON-SURGICAL ISOLATION GOWN |
| Product Code | OEA |
| Date Received | 2019-04-25 |
| Model Number | 2202CV |
| Catalog Number | 2202CV |
| Lot Number | 18KFPNA033 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANGSU WONDERFUL NONWOVEN TECH. CO., LTD |
| Manufacturer Address | 302 BEIJING EAST RD SIYANG, SUQIAN CITY, JIANGSU 223700 CH 223700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-25 |