MAUDE Adverse Event Report: INNOVATIVE PRODUCTS UNLIMITED, INC. DIRECT SUPPLY FOLDING SHOWER BED; CHAIR, ADJUSTABLE MECHANICAL

Model Number FSG350

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Hematoma (1884)

Event Date 07/16/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, patient was placed on gurney for shower.The pin holding the leg of the top portion popped out, resulting in patient falling to floor.Diagnosed with scalp hematoma and wedge compression fracture.

• Brand Name: DIRECT SUPPLY FOLDING SHOWER BED
• Type of Device: CHAIR, ADJUSTABLE MECHANICAL
• Manufacturer (Section D): INNOVATIVE PRODUCTS UNLIMITED, INC. ; niles MI
• MDR Report Key: 7910358
• MDR Text Key: 121895729
• Report Number: MW5080118
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FSG350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 57