MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PAIN RELIEF SYSTEM WITH SILVERSOAKER ANTIMICROBIAL CATHETER, 100ML, 2ML/HR; KITS

Model Number PM012-A

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

Patient Problems Edema (1820); Swelling (2091); Tachycardia (2095); Reaction (2414); No Code Available (3191)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the device history record is in-progress.The actual sample was not returned for further evaluation; however, a photograph of the device was provided.All information reasonably known as of 11-sep-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.(b)(6) 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 (b)(6) medical, inc.Complaint database and identified as complaint (b)(4).

Event Description

Fill volume: unknown, flow rate: unknown, procedure: surgery, cathplace: right lower extremity per the images provided.It was reported the patient had surgery on the morning of (b)(6) 2020.By the evening the patient was in tachycardia and went to the emergency room (er) where they gave the patient steroids and stated the patient was having an allergic reaction.They kept the pump in and flowing at that time.On the (b)(6) 2020 the patient saw her surgeon who removed the pump and catheter.Over 6-days the patient developed edema, blistering and redness from the area where the catheter and the steri-strips were put on the skin.The patient had wounds that were weeping from so much edema.The patient has known allergies to steri-strips and vinyl along with many pain drugs and tetanus shots.The patient is seeing an immunologist.The patient stated that surgeon was aware of her allergies and yet still placed steri-stips on her.

Manufacturer Narrative

The dhr evaluation was not possible because the lot number provided was not a valid avanos lot number.The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided and confirmed the reported incident.A root cause was inappropriate use.All information reasonably known as of 25-nov-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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SILVERSOAKER ANTIMICROBIAL CATHETER, 100ML, 2ML/HR
• Type of Device: KITS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10525359
• MDR Text Key: 212142316
• Report Number: 2026095-2020-00116
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PM012-A
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 11/26/2020
• Patient Sequence Number: 1
• Treatment: STERI-STRIPS
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 109