Catalog Number 062941 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hemorrhage/Bleeding (1888); Perforation (2001); Peritonitis (2252); Post Operative Wound Infection (2446)
|
Event Date 02/14/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Stoma site infection is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
|
|
Event Description
|
On (b)(6) 2020, a patient (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2020, the patient experienced a gastric perforation and peritonitis and underwent an unspecified operation.No further treatment information was provided.
|
|
Manufacturer Narrative
|
Reference record (b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
|
|
Event Description
|
Additional information received on (b)(6) 2020: the patient experienced blood loss and a suspicion of gastric bleeding due to the gastric perforation with peritonitis.
|
|
Search Alerts/Recalls
|