MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-22 for TOWEL OR 17X24IN BLUE STERILE 4/PK 28700-004 manufactured by Jianerkang Medical Dressing Co, Ltd.
| Report Number | 1423537-2019-00334 |
| MDR Report Key | 8811618 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-07-22 |
| Date of Report | 2019-08-08 |
| Date of Event | 2019-06-27 |
| Date Facility Aware | 2019-06-27 |
| Date Mfgr Received | 2019-06-27 |
| Device Manufacturer Date | 2019-04-12 |
| Date Added to Maude | 2019-07-22 |
| 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 |
| 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 | JIANERKANG MEDICAL DRESSING CO, LTD |
| Manufacturer Street | NO.1, JIANERKANG ROAD, ZHIXI JIANGSU PROVINCE |
| Manufacturer City | JINTAN CITY 213251 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 213251 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOWEL OR 17X24IN BLUE STERILE 4/PK |
| Generic Name | FIBER, MEDICAL, ABSORBENT |
| Product Code | FRL |
| Date Received | 2019-07-22 |
| Returned To Mfg | 2019-07-18 |
| Catalog Number | 28700-004 |
| Lot Number | 190329-16-SH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANERKANG MEDICAL DRESSING CO, LTD |
| Manufacturer Address | NO.1, JIANERKANG ROAD, ZHIXI JIANGSU PROVINCE JINTAN CITY 213251 CH 213251 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-22 |