MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; WALKER, TRIGGER, FOLDING, 5" WHEELS

Catalog Number MDS86410TRIG

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 06/27/2023

Event Type  Injury  

Event Description

Implant detached due to fall.

Manufacturer Narrative

The customer reported, "he was having pt therapy and he doesnt know how he fell, he just found himself on the floor".Additionally, it was reported "he twisted 1 of his legs and was gushing with blood, nurses came running in and he was in alot of pain, and xray was done and was informed that the implant he had in his legs was detached due to the fall, now he has to be wheelchair bound and cannot walk".No additional information was reported by the customer.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: WALKER, TRIGGER, FOLDING, 5" WHEELS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17346773
• MDR Text Key: 319275674
• Report Number: 1417592-2023-00300
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2023

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 Catalogue Number: MDS86410TRIG
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other