MAUDE Adverse Event Report: DAVOL SURGICAL INNOIVATIONS STATLOCK FOLEY STABILIZATION DEVICE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Tears (2516)

Event Date 06/11/2015

Event Type  Injury  

Event Description

It was reported that upon removal of the statlock device the patient's skin tore off.The device was placed on (b)(4) 2015 and removed on (b)(4) 2015 by a nurse while admitted to a hospital.The patient suffered from chills, fever and shaking.The patient went to a physician, which took a few cultures.The patient was then started on levofloxacin.The patient has vasculitis.

Manufacturer Narrative

This investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

Received two photos of the patient's injury.The actual device was not returned for evaluation.The complaint has been confirmed with an unknown root cause.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use state the following: "do not alter the statlock® device or components.Procedure must be performed by trained personnel with knowledge of anatomical landmarks, safe technique and potential complications" contraindications: known tape or adhesive allergies, application technique, prep: place foley catheter into retainer.Directional arrow should point towards catheter tip, and balloon inflation arm should be next to the hinge.Close lid, being careful to avoid pinching the catheter.Identify securement site by laying the device retainer on the front of the thigh, leaving 2.5 cm of catheter slack between insertion site and the statlock® device retainer.After placing the statlock® stabilization device off to the side, cleanse and degrease the securement site with alcohol per hospital policy.Let skin dry.Apply skin protectant, in direction of hair growth, to area larger than securement site.Allow to dry completely (10-15 seconds).Using permanent marker, write initials and date of application on the statlock® device anchor pad.Note: always secure catheter into the statlock® device retainer before applying adhesive pad on skin.Removal technique.Disengage.Open retainer by pressing release button with thumb, then lift to open.Remove foley catheter from the statlock® device.Dissolve wipe the edge of the pad using at least 5-6 alcohol pads until a corner lifts.Then continue to stroke undersurface of pad with alcohol to dissolve adhesive pad away from skin.The current dfu includes indications on the application and removal to use alcohol." (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: STATLOCK FOLEY STABILIZATION DEVICE
• Manufacturer (Section D): DAVOL SURGICAL INNOIVATIONS; cd, juarez, chih s.a. de c.v. ; MX
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS; ave. roberto fierro #6408; parque industrial aeropuerto; cd, juarez, chih s.a. de c.v. ; MX
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 4911513
• MDR Text Key: 6011949
• Report Number: 1018233-2015-00218
• Device Sequence Number: 1
• Product Code: EYJ
• 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,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• 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?: No
• Date Manufacturer Received: 09/09/2016
• 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