MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-05-17 for ACU10135910 manufactured by Sterilmed, Inc..
[45341291]
The account did not return the device for an investigation to be conducted. The account did however provide a lot number for the complaint device and the device history report was reviewed. There were no discrepancies noted which would indicate a possible cause for the issue.
Patient Sequence No: 1, Text Type: N, H10
[45341292]
It was reported that a patient of a patent foramen ovale closure procedure came into the facility with a fever post procedure. The medical intervention provided was antibiotics for a possible infection. The current status of the patient was unknown. Additional information regarding patient status was requested but is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2016-00028 |
| MDR Report Key | 5660961 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-17 |
| Date of Report | 2016-04-25 |
| Date of Event | 2016-04-07 |
| Date Mfgr Received | 2016-04-20 |
| Device Manufacturer Date | 2015-12-04 |
| Date Added to Maude | 2016-05-17 |
| 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 | JASON ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER |
| Product Code | OWQ |
| Date Received | 2016-05-17 |
| Model Number | ACU10135910 |
| Catalog Number | ACU10135910 |
| Lot Number | 1908454 |
| Device Expiration Date | 2016-12-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-17 |