• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR DH EF PERC PLACEMENT PRODUCTS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98430
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Foreign Body In Patient (2687)
Event Type  malfunction  
Event Description
It was reported the "patient informed of an old gastropexy site (upper left) that never healed properly and he noticed pus coming from the site and he squeezed the pin prick hole 6 weeks ago and then a stainless steel pin came out measuring 1mm in diameter and 10. 5mm long. Unfortunately he lost the pin when visiting the dieticians as he was going to show them. He is very concerned that this was left in his body and the team doing the tube insertion procedure should be informed so this doesn¿t happen again. The old gastropexy site has now healed.
 
Manufacturer Narrative
The actual complaint product was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. Root cause could not be determined. All information reasonably known as of 18-apr-2022 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. 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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR
Type of DeviceDH EF PERC PLACEMENT PRODUCTS
Manufacturer (Section D)
AVANOS MEDICAL INC.
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
AVENT SA DE R.L. DE C.V. (AVENT 1)
circuito industial no.40
colonia obrera
nogales, cp 84048
MX 84048
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key14141997
MDR Text Key295499646
Report Number9611594-2022-00044
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K080253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98430
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-