MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN DEVICE; DH EF PERC PLACEMENT PRODUCTS

Model Number UNKNOWN

Device Problem Mechanical Problem (1384)

Patient Problems Erythema (1840); Local Reaction (2035); Fluid Discharge (2686)

Event Date 11/19/2021

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 (b)(6) 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 (b)(4).

Event Description

The physician reported, "some issues with the safetypexy fasteners.Specifically, the patient developed progressive erythema, induration, and some possible discharge.We ended up treating with keflex + mupirocin for cellulitis antibiotics were started on (b)(6)2021 after concerns was initially raised on (b)(6) 2021.

• Brand Name: UNKNOWN DEVICE
• 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: 13064364
• MDR Text Key: 283690383
• Report Number: 9611594-2021-00190
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention