MAUDE Adverse Event Report: COMPASS HEALTH BRANDS ULTRA PILL SPLLITER; PILL SPLITTER

Model Number 70068

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Laceration(s) (1946)

Event Date 05/30/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

The end-user sustained an injury on memorial day ((b)(6) 2016) from the ultra pill splitter.As she was removing the pill, the blade guard spring broke and came down on her index finger.Because the cut was so deep and wouldn't stop bleeding, she had to go to the er for sutures, a tetanus shot and antibiotics for two weeks.She indicated that, had the blade not hit part of her finger nail, she would have lost the end of her finger.The pill splitter was used to cut a small pain reliever (round one), and was only used for pain relievers.She had the product for 3 months, and had never put it in water.She indicated that she had never cleaned the product, she only turns the product upside down to get the dust out of the tray.Finally, after 4-5 weeks, the deep cut had healed, but she does not have any feeling in the end of her finger.

• Brand Name: ULTRA PILL SPLLITER
• Type of Device: PILL SPLITTER
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 11 morris dr.; suite 111; dartmouth, nova scotia B3B 1 M2; CA B3B 1M2
• Manufacturer (Section G): COMPASS HEALTH BRANDS; 11 morris dr.; suite 111; dartmouth, nova scotia B3B 1 M2; CA B3B 1M2
• Manufacturer Contact: kaycee nichols ; 6753 engle road; middleburg heights, OH 44130 ; 8009471728
• MDR Report Key: 5816768
• MDR Text Key: 50263626
• Report Number: 2182780-2016-00008
• Device Sequence Number: 1
• Product Code: OHY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 70068
• Device Catalogue Number: 70068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention