MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-20 for RAY-COT 60-06 manufactured by American Surgical Company.
| Report Number | 1221144-2019-00001 |
| MDR Report Key | 9734934 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-20 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-13 |
| Date Added to Maude | 2020-02-20 |
| 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 | MS. SASHA SYLVIA |
| Manufacturer Street | 45 CONGRESS STREET SUITE 153 |
| Manufacturer City | SALEM MA 01970 |
| Manufacturer Country | US |
| Manufacturer Postal | 01970 |
| Manufacturer Phone | 7815927200 |
| Manufacturer G1 | AMERICAN SURGICAL COMPANY |
| Manufacturer Street | 45 CONGRESS STREET SUITE 153 |
| Manufacturer City | SALEM MA 01970 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01970 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAY-COT |
| Generic Name | NEUROSURGICAL SPONGE |
| Product Code | HBA |
| Date Received | 2020-02-20 |
| Catalog Number | 60-06 |
| Lot Number | LOT NUMBER UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN SURGICAL COMPANY |
| Manufacturer Address | 45 CONGRESS STREET SUITE 153 SALEM MA 01970 US 01970 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-20 |