MAUDE Adverse Event Report: COOLSYSTEMS, INC. (DBA GAME READY) GAME READY AND LEFT SHOULDER WRAP; COLD- AND INTERMITTENT COMPRESSION

Device Problem Unintended Compatibility (4047)

Patient Problem Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

The complaint does not contain information about the therapy protocol prescribed by dr.(b)(6).Because the matter is in litigation, it has been turned over to the outside counsel for further investigation.

Event Description

Service of summons on 11/05/2019 was the manufacturer's first notice of this event.The patient was instructed to use a game ready system and left shoulder wrap with a breg shoulder brace and sling on (b)(6) 2018 by his physician, dr.(b)(6) as postoperative treatment following superior labrum interior and posterior (slap) surgery on the patient's left arm and hand.It is stated that, on instructions of dr.(b)(6) the devices were modified by making a 3 to 4 inch hole in the breg sling to provide a place for the hose of the game ready shoulder wrap to pass through.The patient claims that compression from the sling or tubing (game ready hose) due to the incompatibility of the products and/or the fitting or placement of the products caused a nerve compression injury to develop resulting in permanent posterior interosseous nerve palsy, paralysis, and disablement of his left arm.

• Brand Name: GAME READY AND LEFT SHOULDER WRAP
• Type of Device: COLD- AND INTERMITTENT COMPRESSION
• Manufacturer (Section D): COOLSYSTEMS, INC. (DBA GAME READY); 1800 sutter street; suite 500; concord CA 94520
• Manufacturer (Section G): COOLSYSTEMS, INC. (DBA GAME READY); 1800 sutter street; suite 500; concord CA 94520
• Manufacturer Contact: arlene alvarez ; 1800 sutter street; suite 500; concord, CA 94520 ; 5109845351
• MDR Report Key: 9342007
• MDR Text Key: 167792978
• Report Number: 2954777-2019-00003
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072620
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability