MAUDE Adverse Event Report: DJO, LLC PLAYMAKER XPERT WRAP, SIZE XL; JOINT, KNEE, EXTERNAL BRACE

Model Number 82-0023-5

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Inflammation (1932)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

The brace was returned for evaluation and no problem was found with the sewing.The brace was scrapped due to apparent contamination.No design or manufacturing fault was found with this brace.The cause of the patient's reported injury could not be determined, though the brace was received in an apparently contaminated condition.

Event Description

It was reported that a seam of the brace caused irritation / inflammation and a wound on the patient after 15 days of use.A physiotherapist reportedly treated / healed the wound via unspecified means.Further information was requested regarding the patient's treatment, but was not provided.

• Brand Name: PLAYMAKER XPERT WRAP, SIZE XL
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 3151 scott street; vista CA 92081 9663
• Manufacturer (Section G): DJO TUNISIE; zone industrielle poudriere 1; aout; sfax, sfax 3002 ; TS 3002
• Manufacturer Contact: brian becker ; 3151 scott street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 8208957
• MDR Text Key: 131893894
• Report Number: 3007615436-2018-00002
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 82-0023-5
• Device Lot Number: 07-26-18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2018
• 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