Catalog Number 497.125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
Event Type
Injury
|
Manufacturer Narrative
|
Patient id/initials, age/date of birth and weight are unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2015 a new veptr was stabilized, ranging from the left fifth lib to the ileum.On (b)(6) 2015 the surgery for adjusting veptr size was performed.On (b)(6) 2016 (b)(6) infection was noticed again.On (b)(6) 2016 the veptr, stabilized between the left fifth lib and the ileum, was removed.The patient has been well.The veptr treatment has been continued.This is report 6 of 9 for (b)(4).
|
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.A device history record review (dhr) was performed for the subject device lot number 7742860.Manufacturing location: (b)(4).Date of manufacture: 28-jul-2014.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Investigation summary: products were not returned.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.There is no allegation of device defect, deficiency or surgical technique error associated with this complaint.As there is no device malfunction alleged and no associated surgical technique error.Complained issue could not be confirmed.No pictures/ no x-rays were provided which would provide additional evidence.Complaint unconfirmed.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|