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U.S. Department of Health and Human Services

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

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AVANOS MEDICAL INC. INTRODUCER KIT FOR JEJUNAL/GASTRIC FEEDING TUBE, 20FR DILATOR DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98437
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Pocket Erosion (2013); No Code Available (3191)
Event Date 04/04/2020
Event Type  Injury  
Manufacturer Narrative
The actual complaint product was not returned for evaluation. Root cause could not be determined. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of 15 apr 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 complaint database and identified as complaint (b)(4).
 
Event Description
It was reported that the suture "made the hole to the stomach larger" and "air have leaked to the peritoneum. " the patient, a child, required surgery. Additional details: the procedure was performed on ((b)(6) 2020 and the placement "looked good. " the patient started having stomach aches, and a new x ray was performed on (b)(6) 2020, which showed free gas in the abdomen, requiring surgery. The air leak had occurred along one anchor suture, and the suture was "chafing bigger holes in the stomach than it should. " per the reporter, "we have not fully understood the patient's underlying diseases, which is why this happened to everything else. " per additional information received 08 apr 2020, the patient has an underlying and unusual tissue problem/disease, and the healthcare provided does not believe the device failed.
 
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Brand NameINTRODUCER KIT FOR JEJUNAL/GASTRIC 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 Key9974070
MDR Text Key188581487
Report Number9611594-2020-00069
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeSW
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
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number98437
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/06/2020
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

Patient Treatment Data
Date Received: 04/17/2020 Patient Sequence Number: 1
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