Model Number 36304 |
Device Problem
Nonstandard Device (1420)
|
Patient Problem
Pain (1994)
|
Event Date 10/14/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
|
|
Event Description
|
It was reported that there was too much adhesive on the male external catheter and it was causing a pain when removing.No medical intervention was reported.Per additional information received via cardinal health on 17-oct-2022, it was reported that there was too much adhesive on the male external catheter and it caused pain when removing.
|
|
Event Description
|
It was reported that there was too much adhesive on the male external catheter and it was causing a pain when removing.No medical intervention was reported.Per additional information received via (b)(6) on 17-oct-2022, it was reported that there was too much adhesive on the male external catheter and it caused pain when removing.
|
|
Manufacturer Narrative
|
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "operator error".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions are needed.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
|
|
Search Alerts/Recalls
|