Model Number ES88182400 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)
|
Patient Problem
No Information (3190)
|
Event Date 08/01/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
|
|
Event Description
|
According to the available information, there was a repositioning of the pump.Additional information received indicated there was a revision of the implant with replacement of implant pump.The pre-operative and post-operative diagnosis was listed as "malpositioned implant".During the revision procedure, it was noted that there was a high riding pump and one of the tubes was shorter than anticipated.
|
|
Manufacturer Narrative
|
The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
|
|
Event Description
|
According to the available information, the device was implanted on (b)(6) 2019.The patient had two in-office visits post implant on (b)(6) 2019 and (b)(6) 2019.On (b)(6) 2019 the pump was revised but remained implanted.It was reported the pump was riding high and one of the tubes was shorter than anticipated.
|
|
Search Alerts/Recalls
|