MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-19 for ACCU-TRACE IUPC INTRAUTERINE PRESSURE CATHETER * manufactured by Kendall.
[2258095]
Intrauterine pressure catheter with simultaneous amnioinfusion capability did not register any pressure. Catheter adjusted and cable changed with no improvement. Catheter removed and new iupc inserted with adequate readings. Defective catheter tip with sensor was inspected by physician. Physician applied pressure to sensor tip and did not get pressure reading on monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2266951 |
| MDR Report Key | 2266951 |
| Date Received | 2011-09-19 |
| Date of Report | 2011-09-19 |
| Date of Event | 2011-09-07 |
| Report Date | 2011-09-19 |
| Date Reported to FDA | 2011-09-19 |
| Date Added to Maude | 2011-09-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-TRACE IUPC INTRAUTERINE PRESSURE CATHETER |
| Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Product Code | KXO |
| Date Received | 2011-09-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 112900 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KENDALL |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-19 |