HEELWEDGE HQ4B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-22 for HEELWEDGE HQ4B manufactured by Darco International, Inc..

MAUDE Entry Details

• Report Number: MW5091258
• MDR Report Key: 9368822
• Date Received: 2019-11-22
• Date of Report: 2019-11-21
• Date of Event: 2019-11-21
• Date Added to Maude: 2019-11-25
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: HEELWEDGE
• Generic Name: ORTHOSIS, CORRECTIVE SHOE
• Product Code: KNP
• Date Received: 2019-11-22
• Catalog Number: HQ4B
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DARCO INTERNATIONAL, INC.

Device Sequence Number: 2

• Brand Name: HEELWEDGE
• Generic Name: ORTHOSIS, CORRECTIVE SHOE
• Product Code: KNP
• Date Received: 2019-11-22
• Catalog Number: HQ4B
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DARCO INTERNATIONAL, INC.

Device Sequence Number: 3

• Brand Name: HEELWEDGE
• Generic Name: ORTHOSIS, CORRECTIVE SHOE
• Product Code: KNP
• Date Received: 2019-11-22
• Catalog Number: HQ4B
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: DARCO INTERNATIONAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-22