Model Number 33103 |
Device Problems
Nonstandard Device (1420); Difficult to Remove (1528)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
|
|
Event Description
|
It was reported that the adhesive of the male external catheter was too strong, making the catheter difficult to remove.
|
|
Event Description
|
It was reported that the adhesive of the male external catheter was too strong, making the catheter difficult to remove.
|
|
Manufacturer Narrative
|
The reported event could not be confirmed.The preliminary visual inspection noted no obvious defects.Upon evaluation, it was noted that the returned device was used.Therefore, no functional evaluation was able to be performed due to the poor sample condition.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "description/indication the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Precaution: do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply: wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Unroll self-adhering catheter over penis.Gently squeeze the catheter to properly seal adhesive to the skin.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.Connect to drainage device.Directions: to remove: gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.
|
|
Search Alerts/Recalls
|