|
Catalog Number 903016 |
Patient Outcome
Other;
|
Event Description
|
Attempted to inflate (test) balloon prior to insertion into the pt.
The balloon would not inflate at the tip of the catheter but rather at the y site.
|
|
Search Alerts/Recalls
|
|
|
Brand Name | BARD FOLEY |
Type of Device | 16F FOLEY CATH TRAY WITH UROMETER |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section D) |
BARD UROLOGICAL |
8195 industrial blvd ne |
covington GA 30209 2656 |
|
Device Event Key | 380315 |
MDR Report Key | 391266 |
Event Key | 369566 |
Report Number | MW1024837 |
Device Sequence Number | 1 |
Product Code | KOD |
Report Source |
Voluntary
|
Report Date |
04/26/2002 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 04/26/2002 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 903016 |
Device LOT Number | 76JLL718 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 04/23/2002 |
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
No Answer Provided
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|
|
Database last updated on January 30, 2009
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