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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 Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer. The device history record for lot 30012240 was reviewed and the product was produced according to product specifications. All information reasonably known as of 01 dec 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. 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 complaint database and identified as complaint (b)(4).
 
Event Description
Avanos medical inc. Received a single report that referenced two different incidences, which were associated with separate kits, involving the same patient. This is the first of two reports. 9611594-2020-00239 for the second report. It was reported that the sutures broke during the procedure. All four sutures provided in the kit broke. A second and third kit were opened to complete the procedure. The user reported that the suture seemed to be dry and fragile. There was no injury to the patient. Per additional information from the distributor received 24 nov 2020, the patient is male, in his fifties, and has a normal weight. The procedure was able to be completed without consequences to the patient.
 
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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 Key10935054
MDR Text Key222028830
Report Number9611594-2020-00238
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K080253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2021
Device Model Number98432
Device Catalogue NumberN/A
Device Lot Number30012240
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2019
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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