MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-07-25 for WALLACE OOCYTE RECOVERY SYSTEM ONS1733 manufactured by Smiths Medical International Ltd..
[3638138]
A user facility reported that 3 patients reported to hospital reporting abdominal pain following egg collection procedure with the devices listed. The patients have recovered with no reported incident related medical sequela. This report is for patient number two.
Patient Sequence No: 1, Text Type: D, B5
[11058164]
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2013-00415 |
| MDR Report Key | 3267891 |
| Report Source | 01,06 |
| Date Received | 2013-07-25 |
| Date of Report | 2013-07-23 |
| Date of Event | 2013-06-26 |
| Date Facility Aware | 2013-06-26 |
| Report Date | 2013-07-23 |
| Date Reported to FDA | 2013-07-23 |
| Date Mfgr Received | 2013-06-26 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2013-08-08 |
| 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 | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDRY ROAD |
| Manufacturer City | HYTHE, KENT CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT21 6JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLACE OOCYTE RECOVERY SYSTEM |
| Generic Name | MQE- NEEDLE, ASSISTED REPRODUCTION |
| Product Code | MQE |
| Date Received | 2013-07-25 |
| Model Number | NA |
| Catalog Number | ONS1733 |
| Lot Number | 2373715 |
| ID Number | NA |
| Device Expiration Date | 2018-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Address | HYTHE, KENT UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-07-25 |