MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN ELASTOMERIC PUMP; ELASTOMERIC - SAF

Model Number UNKNOWN

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

Patient Problems Bruise/Contusion (1754); Swelling (2091)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history record is not possible as no lot number was provided.The actual sample device was not received.The photos will be reviewed as part of the complaint investigation.Follow-up report will be submitted upon investigation approval.All information reasonably known as of (b)(6) 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

Fill volume: unknown.Flow rate: unknown.Procedure: total knee replacement, left knee.Cathplace: knee.Date or procedure: (b)(6) 2020.It was reported had a total knee replacement on (b)(6) 2020 called on (b)(6) 2020 and reported swelling and bruising the size of a cantaloupe at the catheter insertion site that began 2-days ago.The swelling and bruising had worsened over time.The patient was advised to clamp off medication and to contact physician.Additionally, the patient had some medication left in the pump.The surgeon advised the patient to after receiving a description from the patient.The patient had already discarded the pump.The patient reported she wasn¿t in pain, the catheter insertion site just looked bad.No additional intervention was required.

Manufacturer Narrative

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 not identified.All information reasonably known as of 26-oct-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: UNKNOWN ELASTOMERIC PUMP
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10405020
• MDR Text Key: 207333977
• Report Number: 2026095-2020-00111
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other