MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-02-14 for WALLACE OOCYTE SET RECOVERY SYSTEM ONS1733 manufactured by Smiths Medical International Ltd..
[4287851]
On (b)(4) 2013, the manufacturer submitted medwatch reports: 2183502-2013-00415 through 2183502-2013-00417 with regards to a report from a user facility that 3 pts reported to hospital reporting abdominal pain following egg collection procedure with the devices listed. The pts have recovered with no reported incident related medical sequela. Additional info has been received after the initial medwatch reports were submitted that indicated a fourth patient was also admitted to hospital following an egg collection procedure. According to reporter, the fourth pt was admitted to hospital care for abdominal pain and vomiting. During pt examination (laparoscopy and laparotomy), the pt was shown to have abdominal bleeding from the ovarian puncture site. Pt was given blood transfusion as a result. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
[11648053]
One product sample was received for evaluation. Visual evaluation of the returned needle found no deformities. Functional tip penetration testing found the product sample operated as intended and was within specification. There was no evidence found to suggest the event was caused from an intrinsic device problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2013-00927 |
| MDR Report Key | 3650189 |
| Report Source | 01,06 |
| Date Received | 2014-02-14 |
| Date of Report | 2014-02-13 |
| Date of Event | 2013-06-26 |
| Date Facility Aware | 2013-06-26 |
| Report Date | 2014-02-13 |
| Date Reported to FDA | 2014-02-13 |
| Date Mfgr Received | 2013-06-26 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2014-02-28 |
| 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 |
| Removal Correction Number | ONE PRODUCT SAMPLE WAS R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLACE OOCYTE SET RECOVERY SYSTEM |
| Generic Name | MQE - NEEDLE, ASSISTED REPRODUCTION |
| Product Code | MQE |
| Date Received | 2014-02-14 |
| Returned To Mfg | 2013-07-16 |
| Model Number | NA |
| Catalog Number | ONS1733 |
| Lot Number | 2373715 |
| ID Number | NA |
| Device Expiration Date | 2018-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| 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; 2. Required No Informationntervention | 2014-02-14 |