MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for N/A DIAGNOSTIC ULTRASOUND CATHETER, 8F 10439011 manufactured by Sterilmed, Inc..
[141178915]
Poor image. We have been working with the reps for those issues. Those are reprocessed catheters. The reps have been trying to trouble shoot and tried several things. So far no answers yet. This catheter was approved by fda for reprocessing. That is why we are asking to report because it might be something at the reprocess center.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8490930 |
| MDR Report Key | 8490930 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-02-21 |
| Report Date | 2019-03-26 |
| Date Reported to FDA | 2019-03-26 |
| Date Reported to Mfgr | 2019-04-08 |
| Date Added to Maude | 2019-04-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A DIAGNOSTIC ULTRASOUND CATHETER, 8F |
| Generic Name | REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER |
| Product Code | OWQ |
| Date Received | 2019-04-08 |
| Catalog Number | 10439011 |
| Lot Number | 2084323 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PKWY N STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |