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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR DH EF PERC PLACEMENT PRODUCTS

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AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98432
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 02/21/2022
Event Type  malfunction  
Event Description
It was reported " the patient had a gastrostomy tube placed on (b)(6) 2021. On (b)(6) 2022, the patient had an emergency consultation for abdominal pain, an inflammatory placard with pus discharge at the gastrostomy orifice. During the care, removal of one of the anchors through the stoma orifice. An abdomino-pelvic scanner was performed, but no subcutaneous abscess was found. The biological work-up did not reveal any inflammatory syndrome. According to the doctor who placed the probe, one of the anchors could have been positioned outside the stomach during the placement. The anchor was visible in the abdominal wall during a computed tomography (ct). Medical treatment in place: initiation of antibiotherapy (pristinamycin) for 8-days to manage the infection. The gastrostomy remained functional.
 
Manufacturer Narrative
The device history record for the reported lot number, 30129217,in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements. The actual complaint product was not returned for evaluation. All information reasonably known as of 21-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).
 
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Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR 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 Key14215497
MDR Text Key290152299
Report Number9611594-2022-00046
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K080253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number98432
Device Catalogue NumberN/A
Device Lot Number30129217
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/26/2022 Patient Sequence Number: 1
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