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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD. COOL PERI-PAD; PACK, HOT OR COLD, DISPOSABLE
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DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD. COOL PERI-PAD; PACK, HOT OR COLD, DISPOSABLE Back to Search Results
Model Number CP24
Device Problem Material Rupture (1546)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2014
Event Type  Injury  
Event Description
During activation of the cold pack, the pad and outer bag ruptured.Fluid from the pad came into contact with a nurse's eye causing irritation.After rinsing her eye for 10 minutes, the nurse was sent to the emergency room where her eye was washed for an additional 5 to 10 minutes.A ph test indicated normal limits and a dye test detected a burn located in the lower part of her right eye, with no pitting observed.The nurse was provided saline if her eye became dry and returned to work.During a follow-up examination on (b)(6), the burn was no longer detectable.
 
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Brand Name
COOL PERI-PAD
Type of Device
PACK, HOT OR COLD, DISPOSABLE
Manufacturer (Section D)
DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD.
eyeglasses industrial park
danfu rd.
danyang 2123 00
CH  212300
MDR Report Key3809646
MDR Text Key4524779
Report Number3008403546-2014-00001
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/25/2014,03/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCP24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/25/2014
Distributor Facility Aware Date03/31/2014
Event Location Hospital
Date Report to Manufacturer04/25/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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