MAUDE Adverse Event Report: SHENZHEN KOMI INDUSTRIAL CO., LT KKOOMI ARM SLING; SLING, ARM

Model Number KM015

Patient Problems Fatigue (1849); Headache (1880); Nausea (1970); Dizziness (2194); Malaise (2359); Swelling/ Edema (4577)

Event Date 09/07/2023

Event Type  Injury  

Event Description

I bought an arm sling from amazon brand name kkoomi #km015.I did not notice any unusual smell when i opened the product.I wore it for a day and a half and began having terrible headaches, nausea, dizziness, bilateral ankle & calf swelling, extreme fatigue & general malaise.I noticed the sling had a strong chemical smell.I took it off, showered and drank a generous amount of water.My symptoms started to decrease and by (b)(6) 2023 i only had slight swelling in my feet.I felt much better.I am 65 years old, i am a registered nurse, master of science in nursing, i am semi-retired.I teach nursing at (b)(6) college.I do not have any medical conditions, i don't take any medication every day.I only take vitamin d daily.I took my temperature 98., pulse 72, blood pressure 114/72.No other symptoms.

• Brand Name: KKOOMI ARM SLING
• Type of Device: SLING, ARM
• Manufacturer (Section D): SHENZHEN KOMI INDUSTRIAL CO., LT; 17a02, jueshi bldg no. 4018 jiabin rd; heping comm., nanhu st.; luohu dist., shenzhen, guangdong ; CH
• MDR Report Key: 17745591
• MDR Text Key: 323530324
• Report Number: MW5145641
• Device Sequence Number: 1
• Product Code: ILI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: KM015
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: VITAMIN D 2000 IEU DAILY.
• Patient Outcome(s): Disability
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White