MAUDE Adverse Event Report: DJO LLC LONG THUMB SPICA II (LTSII), FOREARM BASED, BLK, XS, L; ORTHOSIS, LIMB BRACE

Model Number 232-31-1111

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that a (b)(6) year male was provided an exos long thumb spica ii (ltsii), forearm based brace for a fractured hand.After one week, he returned to the physician and it was reported that his arm was allegedly infected due to use.The ifu states the following: "it is imperative that the inside surface of the brace and the patient's skin underneath are completely dry after swimming or bathing.A clean and dry environment inside the brace will help maintain healthy skin and reduce odor and skin issues.Exos® braces are meant to be worn under light pressure and not tight to the skin.A little wiggle room inside an exos® brace promotes air circulation and helps maintain healthy dry skin.An over-tightened brace creates "shear" or pressure on the skin during motion, and can result in irritation, rash, odor, or skin issues".The ifu also states that it is not made with natural or rubber latex.If the product is returned for evaluation, a supplemental report will be submitted.

Event Description

It was reported that an (b)(6) year male was provided an exos long thumb spica ii (ltsii), forearm based brace for a fractured hand.After one week, he returned to the physician and it was reported that his arm was allegedly infected due to use.

• Brand Name: LONG THUMB SPICA II (LTSII), FOREARM BASED, BLK, XS, L
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): DJO LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el flirdo; tijuana, b.c. 22244 ; MX 22244
• Manufacturer Contact: jim pomeroy ; 1430 decision street; vista, CA 92081 ; 5128346301
• MDR Report Key: 12051556
• MDR Text Key: 258021693
• Report Number: 9616086-2021-00010
• 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: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 232-31-1111
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 YR