MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. SOFT TOUCH ® LANCET

Catalog Number 11488481190

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Date 04/13/2013

Event Type  Injury  

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Event Description

It was reported that the patient stuck herself with the soft touch lancet by accident when she was changing the lancet.The patient's finger swelled and she drove herself to the family doctor.The doctor prescribed her with antibiotics.The type and amount of antibiotics was not provided.The patient was not admitted into the hospital.The lancet lot number was not provided.Return of the suspect lancet was requested for evaluation.

• Brand Name: SOFT TOUCH ® LANCET
• Type of Device: LANCET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): FACET TECHNOLOGIES LLC; 3900 north commerce drive; na; atlanta GA 30344
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 6527116
• MDR Text Key: 73862699
• Report Number: 3011393376-2017-02432
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

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 Catalogue Number: 11488481190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 07/16/2017
• Supplement Dates FDA Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention