MAUDE Adverse Event Report: CAREX; BAR,GRAB,SUCTION,12/CS

Catalog Number	CVS792495
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Swelling/ Edema (4577)
Date of Event	07/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, he went to grab the bar while in the shower and the "suction cups came off the shower wall" causing him to fall and hurt his "hip and lower back".The customer reported he required assistance to get up after the reported incident occurred and had "pain, bruising, and swelling".The customer reported his doctor is administering a "steroid injection in a few days" for his left hip and has ordered physical therapy.Sample requested for return evaluation.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.
Event or Problem Description
According to the customer, he went to grab the bar while in the shower and the "suction cups came off the shower wall" causing him to fall and hurt his "hip and lower back".
Additional Manufacturer Narrative
Update to d3: manufacturer, update to d9: sample received, update to h3: device evaluated, update to h6: type of investigation, update to h6: investigation conclusions.The reported issue is associated with a non-medline labeled product.The sample received came with the original packaging which is labelled as carex.After further investigation it has been determined that this is a carex product.The initial reported issue is not reportable by medline industries, lp.A third-party notification was performed with carex.No further regulatory investigation will be performed by medline industries, lp.Related to this incident.If additional information becomes available this report will be reopened and reevaluated.

• Common Device Name: BAR,GRAB,SUCTION,12/CS
• Manufacturer (Section D): CAREX; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17711565
• Report Number: 1417592-2023-00369
• Device Sequence Number: 2250977
• Product Code: ILS
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: CVS792495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown