MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-07-17 for WALLACE? OOCYTE RECOVERY SET ONS1733 manufactured by Smiths Medical Asd, Inc..
[80192932]
Customer has not returned the device to the manufacturer for device evaluation. 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
[80192933]
It was reported that there was "too much bleeding" associated with the use of a wallace oocyte recovery set. No permanent injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[106181737]
Patient Sequence No: 1, Text Type: N, H10
[106181738]
It was then reported that bleeding was related to a patient issue than a device problem. The reporter withdrew the complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2017-01481 |
| MDR Report Key | 6718447 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-07-17 |
| Date of Report | 2017-08-16 |
| Date Mfgr Received | 2017-07-20 |
| Date Added to Maude | 2017-07-17 |
| 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 | JENNIFER MENG |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833078 |
| Manufacturer G1 | SMITHS HEALTHCARE MANUFACTURING SA DE CV |
| Manufacturer Street | CARRETERA MIGUEL ALEM PARQUE INDUSTRIAL MONTERREY |
| Manufacturer City | APODACA, NL CP 66603 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP 66603 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLACE? OOCYTE RECOVERY SET |
| Generic Name | NEEDLE, ASSISTED REPRODUCTION |
| Product Code | MQE |
| Date Received | 2017-07-17 |
| Catalog Number | ONS1733 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-17 |