MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR, POSH, PINK, ZEBRA

Catalog Number MDS86835SHE

Device Problem Collapse (1099)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported that when she sat down on the rollator the left side of the device collapsed and she fell down on the bathroom floor.The customer stated that she was using the device after a spinal fusion surgery and only used the device on and off for 6 to 8 weeks prior to the fall so she could use the seat for breaks.The morning that the device collapsed and the customer reported that she fell on the floor and was able to get back up with the help of her husband.The customer stated that she did not need to seek medical attention because she felt that the soreness was something that her body would just [?]get over'.The fall reportedly occurred in the beginning of (b)(6) 2020 and the customer reported that she had continuous left shoulder pain that she finally went in to get evaluated in (b)(6) 2020.The customer stated that her doctor sent her to an orthopedic specialist who ordered an mri.The customer stated that the mri results showed that she had a torn rotator cuff but the orthopedic specialist decided that surgery wasn't necessary and he gave jean a methylprednisolone injection in her left shoulder.The customer was asked which part of the rollator collapsed and the customer stated she was unsure.This writer requested the device back for evaluation and the customer stated that she does have the device however she would not return the device for evaluation at this time because she does not have an attorney yet.Due to the reported allegation and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

The customer reported that she sat down on the rollator when the left side of the device collapsed and she fell to the ground.

• Type of Device: ROLLATOR, POSH, PINK, ZEBRA
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 10770612
• MDR Text Key: 214139320
• Report Number: 1417592-2020-00133
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86835SHE
• Device Lot Number: 86718110005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 73