MAUDE Adverse Event Report: JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. HENRY SCHEIN; COMPRESS COLD INSTANT DISPOSABLE

Catalog Number 112-6145

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 11/11/2017

Event Type  Injury  

Event Description

Per a letter from a female patient, she reports experiencing lower back pain and placed a cold pack wrapped in a towel on her lower back.Shortly after when the cold pack was removed, she noticed a burn on her back which required medical attention.She is still receiving medical attention for this wound; however no specifics was provided regarding the medical treatment received.

Event Description

The initial report submitted on 02/08/2018 for this incident the patient provided us with the incorrect catalog number.We were informed on 2/21/2018 by our insurance carrier the patient reported the actual catalog number involved and used by the patient as catalog number 112-6145.This item is manufactured by a different manufacturer; therefore, we have sent the report to the manufacturer of this product and have updated the information on: suspect medical device and the manufacturer information: user facility/importer on this medwatch report.

• Brand Name: HENRY SCHEIN
• Type of Device: COMPRESS COLD INSTANT DISPOSABLE
• Manufacturer (Section D): JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.; no. 77 yandunshan road; dagang district; zhenjiang, jiangsu, china TN 21213 ; CH 21213
• MDR Report Key: 7253266
• MDR Text Key: 99602526
• Report Number: 2411236-2018-00002
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/14/2018,02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 112-6145
• Device Lot Number: 015HSN7006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2018
• Distributor Facility Aware Date: 02/21/2018
• Event Location: Home
• Date Report to Manufacturer: 03/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other