MAUDE Adverse Event Report: DARCO INTERNATIONAL, INC. HEELWEDGE ; ORTHOSIS, CORRECTIVE SHOE

Catalog Number HQ4B

Device Problems Break (1069); Product Quality Problem (1506)

Patient Problem Fall (1848)

Event Date 11/21/2019

Event Type  malfunction  

Event Description

A darco heelwedge off-loading shoe, cat #hq4b failed when the strap d-shaped plastic ring used to secure the foot strap came off due to poor stitching quality.This is the third time this product has failed while in use by me.Each time has caused a minor fall not requiring medical attention.Since i have gone through 3 of these shoes over the last 4 months with similar problems.I believe the mfr has a quality problem in consistent with fda gmp practices.Fda safety report id# (b)(4).

• Brand Name: HEELWEDGE
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DARCO INTERNATIONAL, INC.
• MDR Report Key: 9368822
• MDR Text Key: 167824206
• Report Number: MW5091258
• Device Sequence Number: 1
• Product Code: KNP
• 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: 11/21/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: HQ4B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 98