MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-14 for CVS HEALTH UPC#050428307274 935683 manufactured by Suzhou Industrial Park Vicon Hygienic Material Co..
| Report Number | 1038758-2019-00051 |
| MDR Report Key | 9323647 |
| Date Received | 2019-11-14 |
| Date of Report | 2019-10-15 |
| Date of Event | 2019-09-06 |
| Report Date | 2019-09-08 |
| Date Reported to Mfgr | 2019-09-08 |
| Date Mfgr Received | 2019-09-08 |
| Device Manufacturer Date | 2016-02-17 |
| Date Added to Maude | 2019-11-14 |
| 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 | MR. FEDERICO JULIAO |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal | 34240 |
| Manufacturer G1 | ASO LLC |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34240 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CVS HEALTH |
| Generic Name | NON-STICK PADS |
| Product Code | NAC |
| Date Received | 2019-11-14 |
| Model Number | UPC#050428307274 |
| Catalog Number | 935683 |
| Lot Number | 2384-20160217 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUZHOU INDUSTRIAL PARK VICON HYGIENIC MATERIAL CO. |
| Manufacturer Address | NO.18, ZHIHE DONG ROAD SUZHOU INDUSTRIAL PARK SUZHOU, 215122 CH 215122 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-14 |