MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-12-22 for HUTPLUS, LEFT FIXED, COLOR MONIT 400026 manufactured by Liebel-flarsheim Co.
[2569001]
On (b)(6), customer reported the urology system fluoro failed during a pt procedure. Product monitoring has made multiple attempts to contact customer for pt and procedural info without success. Customer stated to lf service tech support inquiry to pt or staff injury, no injuries involved.
Patient Sequence No: 1, Text Type: D, B5
[9584065]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00250 |
| MDR Report Key | 2422631 |
| Report Source | 05,06,07 |
| Date Received | 2011-12-22 |
| Date of Report | 2011-12-22 |
| Date of Event | 2011-12-07 |
| Date Mfgr Received | 2011-12-07 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 2012-07-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH RD. |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUTPLUS, LEFT FIXED, COLOR MONIT |
| Generic Name | UROLOGY SUITE |
| Product Code | KQS |
| Date Received | 2011-12-22 |
| Model Number | HUTPLUS |
| Catalog Number | 400026 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM CO |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-22 |