MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR, BARIATRIC, BASIC STEEL

Catalog Number MDS86800XWS

Device Problem Break (1069)

Patient Problem Post Traumatic Wound Infection (2447)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that customer was walking on the sidewalk when the back right wheel of the rollator popped off resulting in a fall.The customer stated that the fall resulted in a scrape to the left midfoot and three weeks later, the scrape developed into an ulcer infected with (b)(6).The customer stated that at the time of the incident, the customer was wearing two pairs of socks and orthopedic shoes that were in use for a history of ulcers on the left foot.The customer reportedly did not seek medical care at the time of the incident.The customer underwent debridement of the ulcer with a skin graft, stayed in the hospital for five days of intravenous antibiotics, and continued two more weeks of intravenous antibiotics at home.The customer's ulcer is reportedly healing well at this time.The sample has been returned and evaluated.The sample was found to be in used condition and the complaint was confirmed.The root cause identified was maintenance issue.Due to the reported incident and need for medical and surgical intervention, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that customer was walking using the rollator when the back right wheel of the rollator popped off resulting in a fall.

• Type of Device: ROLLATOR, BARIATRIC, BASIC STEEL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 7348121
• MDR Text Key: 102713154
• Report Number: 1417592-2018-00015
• 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: Patient
• Type of Report: Initial
• Report Date: 03/15/2018

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: Lay User/Patient
• Device Catalogue Number: MDS86800XWS
• Device Lot Number: 88517050011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 64