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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY* T-FASTENERS DH EF PERC PLACEMENT PRODUCTS

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AVANOS MEDICAL INC. GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY* T-FASTENERS DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98701
Device Problem Separation Failure (2547)
Patient Problems Bacterial Infection (1735); Foreign Body In Patient (2687)
Event Date 10/25/2021
Event Type  Injury  
Manufacturer Narrative
The device history record for the reported lot number in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements. The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided. All information reasonably known as of 30-nov-2021 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 (b)(4).
 
Event Description
It was reported "the t-fastener suture never dissolved. " the patient was seen at the medical center for g-tube placement that had t-tacks placed. The patient ended up having to have surgery because the t-tack never dissolved. The patient ended up getting (b)(6). Additional information received 11-nov-2021 noted the gastrostomy tube was placed on (b)(6) 2021. Skin infection and purulent drainage were noted. On (b)(6) 2021 the patient underwent wound exploration and excision of gastrostomy site with foreign body. An fda medwatch/ fda user facility report #mw (b)(4) was received 16-nov-2021 stating: during percutaneous gastrostomy tube placement, t-tracks were used, 1/3 fasteners did not dissolve or fall into the stomach and passed as expected. The t-track adhered to patient's abdomen and became source for (b)(6). The t-track was surgically removed. What was the original intended procedure?: percutaneous gastrostomy tube placement.
 
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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 Key12906182
MDR Text Key283152133
Report Number9611594-2021-00176
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/03/2022
Device Model Number98701
Device Catalogue NumberN/A
Device Lot Number30085819
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2020
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: 11/30/2021 Patient Sequence Number: 1
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