MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-07-10 for DUCARE GAUZE SPONGE, 3" X 3", 12 PLY - NS 90312 manufactured by Derma Sciences, Inc..
| Report Number | 9680091-2019-00006 |
| MDR Report Key | 8775692 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-07-10 |
| Date of Report | 2019-06-14 |
| Date of Event | 2019-06-13 |
| Date Mfgr Received | 2019-08-20 |
| Date Added to Maude | 2019-07-10 |
| 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 | MRS. VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362319 |
| Manufacturer G1 | DERMA SCIENCES, INC. |
| Manufacturer Street | 104 SHORTING ROAD |
| Manufacturer City | TORONTO, ONTARIO M1S 3S4 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | M1S 3S4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUCARE GAUZE SPONGE, 3" X 3", 12 PLY - NS |
| Generic Name | SPONGES |
| Product Code | NAB |
| Date Received | 2019-07-10 |
| Catalog Number | 90312 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DERMA SCIENCES, INC. |
| Manufacturer Address | 104 SHORTING ROAD 104 SHORTING ROAD TORONTO, ONTARIO M1S 3S4 CA M1S 3S4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-10 |