MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-14 for SPY-PHI DRUG DRAPE KIT HH9006 manufactured by Novadaq Technologies.
| Report Number | 3012345110-2019-00009 |
| MDR Report Key | 9188766 |
| Date Received | 2019-10-14 |
| Date of Report | 2019-10-14 |
| Date of Event | 2019-09-18 |
| Date Mfgr Received | 2019-09-18 |
| Device Manufacturer Date | 2019-06-24 |
| Date Added to Maude | 2019-10-14 |
| 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. ROOMI BANERJEE DUA |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | NOVADAQ TECHNOLOGIES |
| Manufacturer Street | 8329 EASTLAKE DRIVE, UNIT 101 BURNABY |
| Manufacturer City | BRITISH COLUMBIA V5A 4W2 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | V5A 4W2 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPY-PHI DRUG DRAPE KIT |
| Generic Name | COVER, BARRIER, PROTECTIVE |
| Product Code | MMP |
| Date Received | 2019-10-14 |
| Catalog Number | HH9006 |
| Lot Number | 1906241 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVADAQ TECHNOLOGIES |
| Manufacturer Address | 8329 EASTLAKE DRIVE, UNIT 101 BURNABY BRITISH COLUMBIA V5A 4W2 CA V5A 4W2 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-14 |