MAUDE Adverse Event Report: HAND BIOMECHANICS LAB, INC. DIGIT WIDGET

Model Number	DWD-232
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Inherent risk that a small portion of patients may have or develope sensitivity to neoprene (<0.1% report rate).Directions for use include, 'cuff is made of neoprene' in the materials section and 'if a patient develops a rash or skin irritation under the cuff, a cotton stockinet may be worn under the cuff' in the cautions section.Neoprene ia a widely used material.Use of neoprene in orthopaedic braces and pads have comparable tissue exposure as the digit widget cuff.Other products made of neoprene include diving suits, cycling chamois, face protection masks and gloves to name a few.
Event or Problem Description
Patient had surgery to install a digit widget external fixation system.Patient reported 4 days post operative that he experienced a contact allergic reaction to the neoprene cuff, a non-invasive post surgery component of the device.He went to the er with a swollen hand covered with blisters: in addition to trouble breathing.He was given prednisone and a topical treatment and he stopped wearing the cuff, latex bands and connector assembly.

• Brand Name: DIGIT WIDGET
• Common Device Name: DIGIT WIDGET
• Manufacturer (Section D): HAND BIOMECHANICS LAB, INC.; 77 scripps drive, suite 104; sacramento, ca
• MDR Report Key: 9883951
• Report Number: 2919128-2020-00004
• Device Sequence Number: 2897222
• Product Code: JDW
• UDI-Device Identifier: 00861994000212
• UDI-Public: (01)00861994000212(17)291201(10)DWD-119-120A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K992970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DWD-232
• Device Catalogue Number: DWD-232
• Device Lot Number: DWD-119-120A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention