MAUDE Adverse Event Report: IFGFIT INC. IFGFIT WEARABLE TECH PRODUCTS FOR POSTURAL IMPROVEMENT FORME POWER BRA; MONITOR, SPINE CURVATURE

Model Number POWER BRA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943)

Event Date 07/24/2021

Event Type  Injury  

Event Description

I received the bra and tried it for a few hours unwashed with the tags on.I noticed that it itched and i had redness, so i washed it in the fine washables (hand wash) soap, i use for all of my running / yoga garments.I then wore it again, and i still had the same red/itchiness under my armpits and around the seams.I thought maybe it was the tag that was bothering me, so again, took it off, re-hand washed it with a long rinse/soak, cut the inside small tag (i still have it though) and tried it again the following day.Same thing happened.Because this never happened before with any material, i am probably reacting to the material or the material used to stitch the seams.The redness/swelling did get worse if i left the garment on.Fda safety report id # (b)(4).

• Brand Name: IFGFIT WEARABLE TECH PRODUCTS FOR POSTURAL IMPROVEMENT FORME POWER BRA
• Type of Device: MONITOR, SPINE CURVATURE
• Manufacturer (Section D): IFGFIT INC.
• MDR Report Key: 12384813
• MDR Text Key: 268971840
• Report Number: MW5103564
• Device Sequence Number: 1
• Product Code: LZW
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: POWER BRA
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 54