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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, 16FR DILATOR DH EF PERC PLACEMENT PRODUCTS

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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 Migration or Expulsion of Device (1395)
Patient Problem Foreign Body In Patient (2687)
Event Type  malfunction  
Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of 02 apr 2019 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 halyard health complaint database and identified as complaint (b)(4).
 
Event Description
It was reported that after having an initial button placement in (b)(6) 2018, in (b)(6) 2019 a small metal rod from the suture button was removed from the site. It's possible to feel the same metal rod on the site of the two other sutures. No further information provided.
 
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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
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key8480820
MDR Text Key141188959
Report Number9611594-2019-00063
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 distributor,foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 09/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98430
Device Catalogue Number991098430
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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