MAUDE Adverse Event Report: HELY AND WEBER KUHL KNAPP HINGED KNEE; ORTHOSIS, LIMB BRACE

Model Number 5658-BLK-L

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2022

Event Type  malfunction  

Event Description

I was given a leg brace size xl for a knee injury the brace was too big and it was falling down.I returned to (b)(6) hospital cast room and the size large was tight it barely closes.I discussed with my orthopedic surgeon and he ordered a different style of brace.(b)(6) would not take the size large back and told me to call (b)(6).As soon as i left i called (b)(6) and the representative stated that they would only charge me for 1 as it was a sizing issue.Since then i received a bill and called back, and now they are saying they will not credit the charge for the one that does not fit.Fda safety report id # (b)(4).

Event Description

I was given a leg brace size xl for a knee injury the brace was too big and it was falling down.I returned to (b)(6) hospital cast room and the size large was tight it barely closes.I discussed with my orthopedic surgeon and he ordered a different style of brace.(b)(6) would not take the size large back and told me to call (b)(6).As soon as i left i called (b)(6) and the representative stated that they would only charge me for 1 as it was a sizing issue.Since then i received a bill and called back, and now they are saying they will not credit the charge for the one that does not fit.Fda safety report id # (b)(4).

• Brand Name: KUHL KNAPP HINGED KNEE
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): HELY AND WEBER
• MDR Report Key: 13584510
• MDR Text Key: 286151552
• Report Number: MW5107641
• Device Sequence Number: 1
• Product Code: IQI
• 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: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5658-BLK-L
• Device Lot Number: 040891
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 2 KG
• Patient Ethnicity: Hispanic
• Patient Race: White