Model Number SCCS1002 |
Device Problem
Fitting Problem (2183)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 10/04/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
|
|
Event Description
|
It was reported that heavy weight might have knocked something loose on the sensica device and they did not remove the tamper seal.They thought something got loose or strained when some of them placed too much weight on the load cell.
|
|
Manufacturer Narrative
|
Upon further review, bd has determined that this mdr was reported in error as it was found that there was no allegation against product.H11: section a through f - the information provided by bd 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 bd.
|
|
Event Description
|
It was reported that heavy weight might have knocked something loose on the sensica device and they did not remove the tamper seal.They thought something got loose or strained when some of them placed too much weight on the load cell.
|
|
Search Alerts/Recalls
|