Model Number 9640-14 |
Device Problem
Loose or Intermittent Connection (1371)
|
Patient Problem
Peritonitis (2252)
|
Event Date 06/16/2023 |
Event Type
Injury
|
Event Description
|
It was reported the percutaneous endoscopic gastrostomy (peg) tube's "silicone locking ring [was] loose, causing peg tube to slip into patient's abdomen.This led to peritonitis and unexpected return to [surgical] theatre" for medical intervention.
|
|
Manufacturer Narrative
|
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 10-jul-2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.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 avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
|
|
Manufacturer Narrative
|
The device history record for the reported lot number, 30229472, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 20-sep-2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.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 avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
|
|
Search Alerts/Recalls
|
|