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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. LAPAROSCOPIC INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22 FR DILATOR DH EF PERC PLACEMENT PRODUCTS

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AVANOS MEDICAL INC. LAPAROSCOPIC INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22 FR DILATOR DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 10237
Device Problem Break (1069)
Patient Problems Sepsis (2067); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/25/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The actual complaint product was not returned for evaluation. A review of the device history record is in-progress. All information reasonably known as of 21-sep-2021 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).
 
Event Description
It was reported via fda medwatch / fda user facility report # mw 5102919 received on 24-aug-2021 the following information: "upon visual inspection detection of 1 broken t-fasteners and 2 missing t-fasteners from g-tube. " additional information received "26-aug-202" stated the patient experience sepsis secondary to approximately 3-liters of tube feeding entering the peritoneum. The patient was taken to the operating room (or) for laparotomy, with washout and a new gastrostomy tube was inserted. The patient was started on a course of intravenous iv antibiotics. The patient continues to recover in the intensive care unit (icu).
 
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Brand NameLAPAROSCOPIC INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22 FR 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 Key12510493
MDR Text Key275252853
Report Number9611594-2021-00129
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/22/2022
Device Model Number10237
Device Catalogue NumberN/A
Device Lot Number30063819
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2020
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: 09/21/2021 Patient Sequence Number: 1
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