MAUDE Adverse Event Report: COOLSYSTEMS, INC. (DBA GAME READY) GRPRO 2.1 AND KNEE WRAP; COLD- AND INTERMITTENT COMPRESSION

Device Problem Missing Information (4053)

Patient Problem Skin Irritation (2076)

Event Date 01/13/2019

Event Type  malfunction  

Manufacturer Narrative

Notification of the reported event was received by coolsystems, inc.On may 13, 2019 via united states postal service letter sent by fda.The letter informed coolsystems, inc.Of the patient-reported adverse event, which was submitted through the fda medwatch program (ref.Mw5086329).Coolsystems, inc.Has completed a query of its internal customer database to retrieve patient contact information based on the initial reporter name disclosed in the medwatch (mw) report.This search identified no matching results.As no initial reporter contact information was provided with the mw, no additional information has been obtained regarding the alleged incident.Based on the limited device description included in the mw (game ready grpro 2.1 and knee wrap) and lack of contact information, the type/model or lot number of knee wrap referenced in the reported event could not be identified or confirmed.Two designs of knee wrap are distributed; straight and articulated.The straight knee wrap is not manufactured with natural rubber latex.The articulated knee wrap may include latex strands that are enclosed within nylon or polyester fibers and located in only the outer securing strap of the wrap.These latex strands do not contact the user/patient, and there have been no prior reports received indicating occurrence of a latex allergy.Investigation to identify contact information of the initial reporter to obtain additional event details is ongoing.

Event Description

On may 13, 2019, coolsystems, inc.Received a letter from the fda with medwatch report #5086329 as an attachment.In this report the event description reads "product did not state that it contained latex.Latex allergy.Fda safety report id# (b)(4)".

• Brand Name: GRPRO 2.1 AND KNEE 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 ; 5109845351
• MDR Report Key: 8661094
• MDR Text Key: 205197962
• Report Number: 2954777-2019-00001
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1