Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
|
Event Date 02/01/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
This event is the same patient for mfr.Report # 3006179046-2018-00100.
|
|
Event Description
|
As per reporter post patient¿s initial procedure with the magec rod patient experienced a medical complication.Patient underwent a revision procedure without reported patient harm.
|
|
Manufacturer Narrative
|
This event is the same patient as 3006179046-2018-00100.
|
|
Event Description
|
Investigation related to complaint (b)(4) noted the parent reported that immediately after initial surgery, the patient experienced loss of bladder and bowel control secondary to hardware malplacement.This required catheter placement for each urination episode; bowel control was lost and required continuous use of diapers.Revision surgery to correct the malplacement resolved the loss of nerve control.
|
|
Search Alerts/Recalls
|