MAUDE Adverse Event Report: SHANGHAI SHENGCHOU PLASTIC PRODUCT CO., LTD. OTTEROO; EXERCISER, NON-MEASURING

Device Problem Defective Component (2292)

Patient Problems Emotional Changes (1831); Erythema (1840)

Event Date 03/25/2022

Event Type  Injury  

Event Description

We used the otterroo during a bath for our almost (b)(6) at the time.We put it on as instructed but noticed after a few minutes of wearing it in the water her face started to turn red and she started to cry like she couldn't breath well.We immediately removed it and she was okay afterwards.It seems like if your child has bigger cheeks and therefore not as much space between neck and chest this makes it hard for them to breath and compress the neck.It is advertised as a fun bath tool for babies.

• Brand Name: OTTEROO
• Type of Device: EXERCISER, NON-MEASURING
• Manufacturer (Section D): SHANGHAI SHENGCHOU PLASTIC PRODUCT CO., LTD.
• MDR Report Key: 14933993
• MDR Text Key: 295413096
• Report Number: MW5110670
• Device Sequence Number: 1
• Product Code: ION
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 MO
• Patient Sex: Female
• Patient Weight: 5 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White