SOFT FIT SUEDE FINISH WRIST BRACE 22-150SMBLK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-11 for SOFT FIT SUEDE FINISH WRIST BRACE 22-150SMBLK manufactured by Fla Orthopedics / Bsn Medical Gmbh.

Event Text Entries

[85810407] The product is a right wrist splint/brace. Fla orthopedics 22-150smblk wrist splint l3908. I have no lot number, the medical supply company never gave me the box to the product. Received friday (b)(6) 2017. By saturday afternoon, the pain in my wrist was intense. It felt like my wrist was being pulled in an unnatural position. I removed the splint and immediately iced my wrist. A few hours later, i tried the brace again. The same pain and discomfort returned. I also had a left splint i had ordered but wasn't currently wearing. I put them both on and compared them. The right wrist support bar was in a completely different position than the left wrist. The left was straight from the palm of my hand down on to my inner forearm. The right started from the same spot on my palm but moved completely to the left side of my inner forearm. I have pictures of both wrists wearing the splints side by side for comparison. I also have pictures of both left and right wrist side by side without the splints showing the swelling caused by the defective splint. I do not have the defective splint. It was returned to the medical supply company i purchased it from on monday (b)(6) 2017 right after i contacted them first thing in the morning about it. They look no action, showed no concern, and offered no apology for the problem. I contacted the mfr about the issue on (b)(6) 2017. I received a general response from them on (b)(6) 2017 thanking me for my feedback and told someone would be contacting me about the issue. I heard back from their returns department on (b)(6) 2017. They contacted the medical supply company and confirmed they had it. I never heard from them again even though they said they would send me a replacement i've emailed them again and gotten no response. I do not know who currently has it. A refill for steroids to deal with the pain and swelling caused was picked up on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5072072
MDR Report Key6854760
Date Received2017-09-11
Date of Report2017-09-07
Date of Event2017-06-24
Date Added to Maude2017-09-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSOFT FIT SUEDE FINISH WRIST BRACE
Generic NameSPLINT, HAND AND COMPONENTS
Product CodeILH
Date Received2017-09-11
Model Number22-150SMBLK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerFLA ORTHOPEDICS / BSN MEDICAL GMBH


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-09-11

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