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

Model Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problems Nerve Damage (1979); Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)

Event Date 01/24/2019

Event Type  malfunction  

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.Root cause could not be determined.All information reasonably known as of 12-nov-2019 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 complaint (b)(4).

Event Description

An fda medwatch / fda user facility report # mw 5090053 was received.The following information was provided: i had neurolysis surgery with an on-q pain pump with left in my surgical site on (date redacted) i had severe burning and horrible pain above the surgical site but below the entrance of the catheter the pain was so severe i went t the hosp i received a burn multiple layers thick with scarring and now have no sensation in my skin in that area and the nerve that was operated on generally has no to little function i am significantly disabled and feel the pump failed and dispensed too much pain medicine i have not worked due to this and now require assistive devices to walk the on-q pump is a dangerous device it evidently can express too much medication by compressing the pump the kind of pump i had did not have any control on it to adjust the flow and can put out too much med just by rolling over on the ball of medication pre-operative nerve function was better than postoperative with significant loss of nerve function surgery was on (date redacted) 2019, but severe pain was on (date redacted) 2019.

• Brand Name: UNKNOWN ELASTOMERIC PUMP
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 9314959
• MDR Text Key: 216655495
• Report Number: 2026095-2019-00182
• Device Sequence Number: 1
• Product Code: MEB
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 10/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other