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..
[45297218]
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
[45297219]
It was reported that a few days after a pfo closure case, the patient came in with an infection at the incision site. It was reported that the medical intervention provided was antibiotics. The status of the patient was unknown. Additional information on patient status was requested, but no further information was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2016-00027 |
| MDR Report Key | 5659308 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-17 |
| Date of Report | 2016-04-21 |
| Date of Event | 2016-04-07 |
| Date Mfgr Received | 2016-04-21 |
| Device Manufacturer Date | 2016-01-16 |
| 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 | 1917149 |
| Device Expiration Date | 2017-01-17 |
| 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 |