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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided. The sample is reported to be available, but has not yet been received by the manufacturer. All information reasonably known as of (b)(6) 2020 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. 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 comp (b)(4).
 
Event Description
Avanos medical inc. Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient. This is the second of two reports. Refer to 9611594-2020-00245 for the first report. It was reported that the anchor wire from a second kit ruptured during the procedure. Another kit was used to complete the procedure. Additional information received 16-dec-2020 indicated that the patient's current status is "fine, no patient consequences. ".
 
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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
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key11038913
MDR Text Key226250762
Report Number9611594-2020-00246
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 distributor,foreign,other,use
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98432
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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