MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-01-31 for KOALA UNKNOWN manufactured by Clinical Innovations, Inc..
[3225917]
During a retrospective review of unexpected fetal outcomes in (b)(6) 2013 it is believed that the following iupc device may have caused or contributed to this fetal demise. Prior to delivery of a laboring patient on (b)(6) 2012, an iupc device was inserted into mother. This iupc device did not appear to be functioning appropriately and a 2nd iupc was deployed. Following this deployment fetal heart tones diminished and an emergent c-section was performed. Infant demise shortly after delivery. At the time of this event it was thought that the death was related to an atypical abruption. Subsequent investigation into this event along with pathology reports and laboratory values indicate that the iupc device may have caused a knick in a placental blood vessel, which may have contributed to a significant loss of fetal blood incompatible with life.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2944237 |
| MDR Report Key | 2944237 |
| Report Source | 99 |
| Date Received | 2013-01-31 |
| Date of Report | 2013-01-29 |
| Date of Event | 2012-09-27 |
| Date Facility Aware | 2012-12-31 |
| Report Date | 2013-01-29 |
| Date Reported to FDA | 2013-01-30 |
| Date Reported to Mfgr | 2013-01-30 |
| Date Added to Maude | 2013-02-05 |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOALA |
| Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Product Code | HFN |
| Date Received | 2013-01-31 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS, INC. |
| Manufacturer Address | 747 WEST 4170 SOUTH MURRAY SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-01-31 |