MAUDE Adverse Event Report: CARDINAL HEALTH COLD PAK MED 6 X 6.5; COMMON NAME PERINEAL COLD PACK

Model Number 11445-020

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Eye Injury (1845)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

The cold pack exploded when being activated and the contents got into a nurse's right eye.She went to urgent care for treatment and they hand irrigated her eye with 1 liter of lactated ringers solution and prescribed antibiotic eye drops.The nurse was evaluated by an ophthalmologist on (b)(6) 2015 and cleared.

Manufacturer Narrative

The complaint was received and forwarded on to the manufacturing facility for investigation.Although catalog number 11445-020 was given, a lot number was not provided; therefore, a complete review of the applicable device history record could not be conducted.Since no sample has been provided, we cannot confirm if there was a failure of the thermal packs seal.Without information as to the lot number or a sample being provided, a more detailed investigation cannot be completed.However, the plant's quality system mandates suitable in-process controls to measure seal integrity of representative samples.Samples are pulled from production and tested at predetermined locations to best gauge the seal integrity.All lots released by the quality unit meet the predetermined criteria.If the actual sample is received, the investigation will be re-opened and a follow report will be filed.

• Brand Name: COLD PAK MED 6 X 6.5
• Type of Device: COMMON NAME PERINEAL COLD PACK
• Manufacturer (Section D): CARDINAL HEALTH; waukegan IL
• Manufacturer (Section G): CARDINAL HEALTH 200, LLC; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 4785681
• MDR Text Key: 5858654
• Report Number: 1423537-2015-00028
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2015

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: Nurse
• Device Model Number: 11445-020
• Device Catalogue Number: 11445-020
• Device Lot Number: NO LOT GIVEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 98