MAUDE Adverse Event Report: DJO LLC COMPRESS COLD/HOT 8X14 CASE/12; PACK, HOT OR COLD, REUSABLE

Catalog Number 4029

Device Problems Unexpected Therapeutic Results (1631); Temperature Problem (3022)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 12/07/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that allegedly the patient sustained a 3rd degree burn after applying cold flexipac to the shoulder for approximately 5 minutes.Enovis has received the flexipac for evaluation, when the evaluation has been completed a supplemental report will be filed.

Event Description

It was reported that allegedly the patient sustained a 3rd degree burn after applying cold flexipac to the shoulder for approximately 5 minutes.

• Brand Name: COMPRESS COLD/HOT 8X14 CASE/12
• Type of Device: PACK, HOT OR COLD, REUSABLE
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245, mex ; MX
• Manufacturer Contact: jim djo llc ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 16098735
• MDR Text Key: 306658165
• Report Number: 9616086-2022-00034
• Device Sequence Number: 1
• Product Code: IME
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 4029
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female