MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-22 for OVUM ASPIRATION NEEDLE SINGLE LUMEN K-OSN-1735-B-90-US manufactured by William A. Cook Australia, Pty Ltd.
[106141932]
Pma/510(k) granted on the (b)(6) 2018: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[106141933]
The patient developed an infection (bilateral tubal ovarian abscess) after having an ovum aspiration (cyst aspiration) performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680654-2018-00015 |
| MDR Report Key | 7449889 |
| Date Received | 2018-04-22 |
| Date of Report | 2018-06-11 |
| Date of Event | 2017-07-22 |
| Date Mfgr Received | 2018-03-26 |
| Date Added to Maude | 2018-04-22 |
| 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 | 2018-04-22 |
| Catalog Number | K-OSN-1735-B-90-US |
| 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 | 2018-04-22 |