MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-18 for SPY ELITE DRUG DRAPE KIT (SPY PAQ) LC3006 manufactured by Novadaq Technologies.
[142494876]
Additional information will be provided once the investigation has been completed. The device manufacturer date is not known at this time. However, should it become available it will be provided in future reports.
Patient Sequence No: 1, Text Type: N, H10
[142494897]
It was reported that there was breach in sterile barrier due to hole in the seam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012345110-2019-00004 |
| MDR Report Key | 8529797 |
| Date Received | 2019-04-18 |
| Date of Report | 2019-08-13 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-03-21 |
| Date Added to Maude | 2019-04-18 |
| 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 CA 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 ELITE DRUG DRAPE KIT (SPY PAQ) |
| Generic Name | ANGIOGRAPHIC X-RAY SYSTEM |
| Product Code | IZI |
| Date Received | 2019-04-18 |
| Catalog Number | LC3006 |
| Lot Number | 19026 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-04-18 |