MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE; UNKOWN FOLEY STATLOCK

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Discoloration (2074); Skin Irritation (2076); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review could not be completed as there was no product catalog # provided.

Event Description

It was reported that the home care staff was unable to get the statlock to stick for the 7 day period.It would fall off frequently within 24 to 72 hours, and skin breakdown was occurring.The client had a medicated cream, that was applied to the old areas of application and not under the new areas.Due to the alleged skin irritation and break down, the staff was cleaning the skin with soap and water, not alcohol, to avoid further irritation.It was reported that it was thought to be the client's oils interfering with the adhesive, or perhaps soap residue left on the skin after cleaning.Additional information was provided by the international business center via email on 21jan2019 that the skin was prepped with a protectant prior to the placement (as recommended in the instructions for use).The process has been reinforced to the complainant.The skin breakdown was described as red, hives and open areas.The previous statlock site skin was healing, but still discolored.The cream prescribed was discontinued 2 weeks prior but was an unknown strength of hydrocortisone.The new statlock site also had skin irritation upon removal, and the statlock was frequently changed persistently.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: UNKOWN FOLEY STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8318593
• MDR Text Key: 135502795
• Report Number: 1018233-2019-00711
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention