MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-06-27 for HARRISON FETAL BLADDER STENT SET J-HFBS-503540 manufactured by Cook, Inc..
[4489385]
A pregnant female underwent fetal post-vesicular obstructive uropathy procedure on (b)(6) 2014. After being placed, the harrison fetal bladder stent catheter moved during pregnancy and had to be replaced. The patient underwent the catheter placement procedure once again, which means a risk to life. A section of the device did not remain inside the patient's body. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[12139654]
Event is not reportable under (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2014-00265 |
| MDR Report Key | 3911577 |
| Report Source | 01,08 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-05-29 |
| Date of Event | 2014-05-20 |
| Report Date | 2014-05-29 |
| Date Mfgr Received | 2014-06-02 |
| Date Added to Maude | 2014-07-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, DIRECTOR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARRISON FETAL BLADDER STENT SET |
| Generic Name | MPR STENT, BLADDER, FETAL |
| Product Code | MPR |
| Date Received | 2014-06-27 |
| Model Number | NA |
| Catalog Number | J-HFBS-503540 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-27 |