MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-09-22 for HUDSON CONCHAPAK COLUMN STD RIGHT ANGLE, INTL 438260 manufactured by Telefelx Medical.
[1466971]
The event is reported as: the upper tube to the sterile water was completely disconnected into 2 pieces without any manipulation. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[8713225]
Product has not yet been received by mfr, therefore, investigation report is incomplete at this time. A f/u investigation report will be sent when completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417411-2010-00035 |
| MDR Report Key | 1860282 |
| Report Source | 01,07 |
| Date Received | 2010-09-22 |
| Date of Report | 2010-09-06 |
| Date of Event | 2010-09-06 |
| Date Mfgr Received | 2010-09-06 |
| Date Added to Maude | 2011-01-27 |
| 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 | MICHAEL TAGGART, VP |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334916 |
| Manufacturer G1 | TELEFELX MEDICAL |
| Manufacturer Street | 900 WEST UNIVERSITY DR. |
| Manufacturer City | ARLINGTON HEIGHTS IL 60004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60004 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON CONCHAPAK COLUMN STD RIGHT ANGLE, INTL |
| Generic Name | CONCHAPAK COLUMN |
| Product Code | BYF |
| Date Received | 2010-09-22 |
| Model Number | NA |
| Catalog Number | 438260 |
| Lot Number | 1704311304 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFELX MEDICAL |
| Manufacturer Address | ARLINGTON HEIGHTS IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-22 |