MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE HOT PACK (DISPOSABLE); INSTANT HOT PACK

Catalog Number MDS139008

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2017

Event Type  malfunction  

Event Description

Manually activated instant hot pack which ruptured upon activation via hand-held squeezing.Pack spread activated liquid to patients hand and chest.

• Brand Name: MEDLINE HOT PACK (DISPOSABLE)
• Type of Device: INSTANT HOT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6547114
• MDR Text Key: 74515339
• Report Number: 6547114
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MDS139008
• Other Device ID Number: 139008BV01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR