MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for ESOPHAGEAL MANOMETRY CATHETER UNI-ESO-WG1A1 CH 8544 manufactured by Diversatek Healthcare, Inc. / Sandhill Scientific, Inc..
[117831288]
Following use, the diversatek healthcare / sandhill esophageal manometry catheter was noted to have exposed copper wires below the most proximal catheter marker bead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079232 |
| MDR Report Key | 7797303 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-08-14 |
| Date Added to Maude | 2018-08-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ESOPHAGEAL MANOMETRY CATHETER |
| Generic Name | MANOMETRY CATHETER |
| Product Code | KLA |
| Date Received | 2018-08-17 |
| Returned To Mfg | 2018-08-16 |
| Model Number | UNI-ESO-WG1A1 |
| Catalog Number | CH 8544 |
| Lot Number | K123245-E-1047-D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIVERSATEK HEALTHCARE, INC. / SANDHILL SCIENTIFIC, INC. |
| Manufacturer Address | HIGHLANDS RANCH CO 80129 US 80129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-17 |