MAUDE Adverse Event Report: LINET SPOL. S R.O. LINET AMERICAS BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number MULTICARE LE 1MC5A650-197

Device Problem Sharp Edges (4013)

Patient Problems Cellulitis (1768); Erythema (1840); Skin Tears (2516); Renal Impairment (4499); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/08/2022

Event Type  Injury  

Event Description

Damage to linet bed lower rail casing.On (b)(6) 2022 the patient experienced a superficial skin tear as a result of an exposed sharp plastic piece on linet bed resulting in right calf cellulitis with underlying venous stasis.Three (3) days post injury patient was afebrile with normal wbc's but compromised and at significant risk for severe infection requiring local wound care.On (b)(6) 2022 patient developed increasing redness relative to said wound requiring iv antibiotic therapy through (b)(6) 2022 then oral antibiotic therapy administered through (b)(6) 2022.Dialysis initiated during this hospitalization.Patient discharged to home (b)(6) 2022.Patient with past medical history of diabetes type 2, coronary artery disease, obesity admitted for acute on chronic hypoxemic respiratory failure, hear failure and pleural effusion.Fda safety report id# (b)(4).

• Brand Name: LINET AMERICAS BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): LINET SPOL. S R.O.
• MDR Report Key: 14014667
• MDR Text Key: 288666892
• Report Number: MW5108748
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MULTICARE LE 1MC5A650-197
• Device Lot Number: 20150075710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 165 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White