MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-08-10 for WALLACE OOCYTE RECOVERY SYSTEMS ON1733 manufactured by Smiths Medical.
[51774647]
Additional manufacturer narrative: 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
[51774648]
Distributor reported that a patient experienced severe abdominal pain and heavy bleeding after a puncture. Additional information has been requested multiple times, if received, a follow up will be sent.
Patient Sequence No: 1, Text Type: D, B5
[60450097]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60450474]
Patient was born in 1971. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60450475]
Additional information: according to the reporter, it could not be determined the exact amount of blood lost; however, the patient lot "quite a lot". The patient received propofol and ibuprofen as treatment. The reported event resulted in hemoperitoneum and 3 days in hospital.
Patient Sequence No: 1, Text Type: D, B5
[67462633]
Three used wallace? Wallace oocyte recovery systems were received inside a plastic bag for investigation. Photographs were also provided for examination. A review of the provided photographs was unable to find defect with the devices, only the echogenic marks were observed. The returned samples were analyzed under microscopically to confirm if there was any damage to the needle tip. All returned samples were found to be within specification. During functional testing, the returned samples were penetration tested; all samples were found to be within specification. Investigation did not find fault with the returned samples and the samples were found to be within manufacturing specification. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2016-01690 |
| MDR Report Key | 5866052 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-08-10 |
| Date of Report | 2016-07-15 |
| Date of Event | 2016-07-05 |
| Date Mfgr Received | 2017-01-20 |
| Device Manufacturer Date | 2015-07-17 |
| Date Added to Maude | 2016-08-10 |
| 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 | LISA PERZ |
| Manufacturer Street | 1265 GREY FOX ROAD |
| Manufacturer City | ST PAUL 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V |
| Manufacturer Street | CARRETERA MIGUEL ALEM PARQUE INDUSTRIAL MONTERREY |
| Manufacturer City | APODACA NL, CP 66603 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 66603 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLACE OOCYTE RECOVERY SYSTEMS |
| Generic Name | NEEDLE, ASSISTED REPRODUCTION |
| Product Code | MQE |
| Date Received | 2016-08-10 |
| Returned To Mfg | 2016-10-21 |
| Catalog Number | ON1733 |
| Lot Number | 3003611 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL |
| Manufacturer Address | 1265 GREY FOX RD. ST PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-10 |