MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC GUARDIAN EASY CARE WALKER

Model Number 30756P

Device Problems Defective Device (2588); Device Fell (4014)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

On friday, september 28, 2018, sunrise medical's legal department received a legal summons from the law offices of (b)(6), stating that their attorney services were retained by their client, claiming serious injury received from a walker distributed by sunrise medical.However, there was no detail as to what the injury was, the type of incident and the conditions in which the incident occurred.Sunrise medical did distribute the guardian walker, however, the product was sold off to (b)(4) in 2008.Since there was no information provided in the summons about the walker, it could not be determined if this walker was a sunrise medical distributed product at the time.On october 12, 2018 a photo of the walker's label was provided and it was shown on that label that the subject walker was manufactured for sunrise medical distribution.The manufacture date for the walker was december of 2004.However, there was still no information provided by the attorneys in regards to the occurrence of the alleged incident and the type of injury sustained by the end user.A letter from the plaintiff's attorney, dated july 2, 2019 was finally produced and forwarded to sunrise medical on july 5, 2019, providing additional detail about the incident.As mentioned in description of problem or event of this report, the end user claims, in this letter, that the walker tipped over causing her to fall and sustain an injury that required stitches.However, there was no description as to how the walker tipped over or what the series of events were that led to the walker tipping over.The claim states that the hinge is what caused the injury.The hinges on the walker is what allows it to fold for storage and are located at the upper right and left hand side near to where the hand grips are located.Again, sunrise medical was not provided any information as to the series of events that led up to the fall and is unable to come to a reasonable determination as to how an injury to the lower ankle area could occur on a part of the walker that is located near to where the hands are positioned.The hinges on the walker is a standard design and is used in several other competitor's walkers.Sunrise medical does not consider this to be a "defectively designed" part or is "unreasonably dangerous for its intended purpose" as stated in the legal summons.Since this is the only reported occurrence of this type, sunrise medical considers this to be an isolated incident and is highly improbable that a similar incident could occur again.This incident is currently being addressed and investigated by sunrise medical's legal department.If any new and relevant information is provided from the case or investigation, sunrise medical will file a supplemental report.A copy of this mdr filing will be forwarded to (b)(4) who is the current distributor of the guardian walker.

Event Description

A letter from the law offices of (b)(6), and dated (b)(6) 2019 was received by sunrise medical's legal department on 7/5/2019.It is alleged in the letter that on (b)(6) 2018 (plaintiff) was attempting to use a walker which had been manufactured for sunrise medical when the walker tipped over causing her to fall.As the result of the fall she sustained a deep laceration to the right ankle area requiring stitches.The claim is that the walker was defectively designed in that the exposed hinge on the walker sliced to client's leg causing severe injury.

• Brand Name: GUARDIAN EASY CARE WALKER
• Type of Device: WALKER
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 8857860
• MDR Text Key: 153801766
• Report Number: 2937137-2019-00021
• Device Sequence Number: 1
• Product Code: NXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 30756P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR