MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-26 for OVUM ASPIRATION NEEDLE SINGLE LUMEN K-OPS-1735-R-B-90 manufactured by William A. Cook Australia, Pty Ltd.
[81432758]
The needles are causing extra bleeding. It was reported that this problem occurred multiple times in the week prior to (b)(6) 2017. The exact quantity was not confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680654-2017-00019 |
| MDR Report Key | 6745862 |
| Date Received | 2017-07-26 |
| Date of Report | 2017-08-16 |
| Date Mfgr Received | 2017-07-10 |
| Date Added to Maude | 2017-07-26 |
| 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 NICOLAS BIDAUD |
| Manufacturer Street | 95 BRANDL STREET EIGHT MILE PLAINS |
| Manufacturer City | BRISBANE, QLD 4113 |
| Manufacturer Country | AU |
| Manufacturer Postal | 4113 |
| Manufacturer Phone | 738411188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OVUM ASPIRATION NEEDLE SINGLE LUMEN |
| Generic Name | MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES |
| Product Code | MQE |
| Date Received | 2017-07-26 |
| Catalog Number | K-OPS-1735-R-B-90 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM A. COOK AUSTRALIA, PTY LTD |
| Manufacturer Address | 95 BRANDL STREET EIGHT MILE PLAINS BRISBANE QLD 4113 AS QLD 4113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-26 |