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

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.

• Type of Device: DH 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 Key: 12906182
• MDR Text Key: 283152133
• Report Number: 9611594-2021-00176
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• 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 Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/03/2022
• Device Model Number: 98701
• Device Catalogue Number: N/A
• Device Lot Number: 30085819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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