MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN PEG INITIAL PLACEMENT PRODUCT DH EF PERC PLACEMENT PRODUCTS

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of 22-jul-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, inc. Complaint database and identified as complaint (b)(4).

Event Description

The patient had an initial placement for a feeding tube in the beginning of (b)(6). Around (b)(6), the patient was seen by the surgeon and it was observed that there was granulation, skin irritation and discharge under the area of one of the t-fasteners. The patient went to another hospital on or around (b)(6) and necrosis was noted, in addition to discharge, pustules, and infection. The patient was placed on keflex and taken to surgery, the t-fastener was removed. The patient's current medical status is unknown. Additional information has been requested.

• Brand Name: UNKNOWN PEG INITIAL PLACEMENT PRODUCT
• 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 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 10326258
• MDR Text Key: 200457155
• Report Number: 9611594-2020-00134
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/01/2020
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/27/2020 Patient Sequence Number: 1

Treatment

KEFLEX