MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE UNKNOWN ON-Q PAINBUSTER; UNKNOWN ELASTOMERIC PUMP

Model Number UNKNOWN

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Weakness (2145); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 30-jan-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

Fill volume: unknown.Flow rate: unknown.Procedure: left shoulder arthroscopy.Cathplace: unknown.It was reported that a patient alleged chondrolysis following placement of an on-q painbuster after a left shoulder arthroscopy in the (b)(6) of 2003.

Event Description

Additional information received 15-feb-2019 stated, the patient underwent left shoulder arthroscopy with debridement and repair in the fall of 2003.Following his surgery, the patient began suffering severe cartilage loss in his left shoulder.Additionally, the patient began suffering severe cartilage loss in his left shoulder.The administration of the anesthetic solution by the pain pump directly led to cartilage and tissue damage in the patient's surgery resulting in severe pain, weakness, and decreased range of motion in his shoulder, and requiring further medical treatment, including the recommendation for future left shoulder arthroplasty or shoulder replacement.The patient's injuries resulted in permanent disability to his left shoulder and limited daily activities.In october of 2017 the patient was evaluated by an orthopedics doctor.The patient was instructed he had chondrolysis of his left shoulder joint and that the cause of his chondrolysis was the postoperative pain pump inserted into his glenohumeral shoulder joint.

Manufacturer Narrative

All information reasonably known as of (b)(6) 2019 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 ON-Q PAINBUSTER
• Type of Device: UNKNOWN ELASTOMERIC PUMP
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8292418
• MDR Text Key: 134583427
• Report Number: 2026095-2019-00018
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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: Other
• 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
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/08/2019
• Patient Sequence Number: 1