MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-10-04 for CVS HEALTH UPC#050428367988 895760 manufactured by Yangzhou Super Union Medical Material Co., Ltd..
[88128777]
As of 10/02/2017 aso did not receive information from the consumer on this lot number and has notified the manufacturer. Satisfactory biocompatibility test results for the materials used to manufacture the same type of products were reviewed.
Patient Sequence No: 1, Text Type: N, H10
[88128778]
Consumer stated that he noticed that one of the items had a grayish-black spot on it. He used an item without the spot and he stated that his wound has gotten worse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2017-00032 |
| MDR Report Key | 6913617 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-10-04 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-09-04 |
| Report Date | 2017-09-21 |
| Date Reported to Mfgr | 2017-09-21 |
| Date Mfgr Received | 2017-09-05 |
| Date Added to Maude | 2017-10-04 |
| 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 | 3 |
| Brand Name | CVS HEALTH |
| Generic Name | STERILE PADS 4X4 IN |
| Product Code | NAB |
| Date Received | 2017-10-04 |
| Model Number | UPC#050428367988 |
| Catalog Number | 895760 |
| Lot Number | 2384-20161215 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YANGZHOU SUPER UNION MEDICAL MATERIAL CO., LTD. |
| Manufacturer Address | 18 SOUTH XISHAN RD CHENJI TOWN, YIZHENG JIANGSU 211408 CH 211408 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-04 |