MAUDE Adverse Event Report: DENTSPLY RAINTREE ESSIX ESSIX RETAINER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091); Weakness (2145)

Event Date 03/11/2015

Event Type  Injury  

Event Description

I started wearing an essix retainer manufactured by dentsply (b)(4).The retainer was prescribed by my dentist who made the retainer in the office.I wore the retainer for one week and started experiencing general weakness, dry mouth, white tongue, swollen lymph nodes and i developed a rash on my arms.Suspecting that these symptoms were related to the retainer, i immediately stopped wearing the retainer and the symptoms slowly disappeared.Needless to say, the whole experience was quite frightening! i hope i haven't done serious damage to my body or internal organs by wearing the retainer.

• Brand Name: ESSIX RETAINER
• Type of Device: RETAINER
• Manufacturer (Section D): DENTSPLY RAINTREE ESSIX
• MDR Report Key: 4609387
• MDR Text Key: 18542934
• Report Number: MW5041465
• Device Sequence Number: 1
• Product Code: EFT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/11/2015

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
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Weight: 50