MAUDE Adverse Event Report: DJO, LLC PROCARE SQUARED TOE POST OP SHOE, M; ORTHOSIS, CORRECTIVE SHOE

Model Number 79-81235

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that "the seal under the sole came loose and the metal brace for rigidity fell out, causing my foot to flex unduly and refractured my 4th metatarsal.I did not seek further treatment.My foot underwent pain until i recognized the shoe failure.I took safety measures until i notified my orthopedic caregiver and bought another shoe from him.I am wearing a shoe to heal from a fracture of my 4th metatarsal.I wore a previous shoe since diagnosed by xray on (b)(6).After weeks of wearing the shoe, a subsequent xray showed significant resorption and i was issued a new shoe on (b)(6) 2019.The new shoe failed recently that caused the same exact pain i've experienced when diagnosed.My foot has the original pain in the exact same location.".

• Brand Name: PROCARE SQUARED TOE POST OP SHOE, M
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• 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 florido; tijuana, b.c. 22244 ; MX 22244
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 9529959
• MDR Text Key: 187798708
• Report Number: 9616086-2019-00088
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 79-81235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention