MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-29 for INTRAUTERINE PRESSURE MONITORING KIT KOALA EXTERNAL REF-IPC-5000E manufactured by Koala.
[19802448]
A koala intrauterine pressure catheter (iupc) did not work properly on pt. It would not show contractions properly. The same problem occurred on the two other patients using iupcs from the same koala box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040575 |
| MDR Report Key | 4484081 |
| Date Received | 2015-01-29 |
| Date of Report | 2015-01-29 |
| Date of Event | 2015-01-23 |
| Date Added to Maude | 2015-02-05 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRAUTERINE PRESSURE MONITORING KIT |
| Generic Name | IUPC |
| Product Code | KXO |
| Date Received | 2015-01-29 |
| Model Number | KOALA EXTERNAL |
| Catalog Number | REF-IPC-5000E |
| Lot Number | 141071 |
| ID Number | +H833IPC5000E1 |
| Device Expiration Date | 2016-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KOALA |
| Manufacturer Address | MURRAY 84123 84123 |
| Brand Name | INTRAUTERINE PRESSURE MONITORING KIT |
| Generic Name | IUPC |
| Product Code | KXO |
| Date Received | 2015-01-29 |
| Model Number | KOALA EXTERNAL |
| Catalog Number | REF-IPC-5000E |
| Lot Number | 141071 |
| ID Number | +H833IPC5000E1 |
| Device Expiration Date | 2016-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | KOALA |
| Manufacturer Address | MURRAY 84123 84123 |
| Brand Name | INTRAUTERINE PRESSURE MONITORING KIT |
| Generic Name | IUPC |
| Product Code | KXO |
| Date Received | 2015-01-29 |
| Model Number | KOALA EXTERNAL |
| Catalog Number | REF-IPC-5000E |
| Lot Number | 141071 |
| ID Number | +H833IPC5000E1 |
| Device Expiration Date | 2016-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | KOALA |
| Manufacturer Address | MURRAY 84123 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-29 |