MAUDE Adverse Event Report: KCI USA, INC. ACTIV.A.C.¿ THERAPY SYSTEM; OMP

Model Number WNDACT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

Based on information provided, this report is being filed due to possible use error.The patient stated her nurse educated her on the proper technique for utilizing the carrying case.It is unknown if and what medical or surgical intervention may have been required.Device labeling, available in print and online, states: the activ.A.C.¿ therapy system quick reference guide 'for patient use' states on page 1 of 2, under section "carrying case options," the activ.A.C.¿ therapy system has an integrated belt loop and a separate adjustable strap to allow for versatile carrying options.Five images exhibit carrying options: the carrying case strap across the body, the carrying case strap through the belt loop, the carrying case buckled around the waist without use of the belt loop, a hand holding the carrying case using the handle, and the carrying case hanging on a bar.Three of the images demonstrate how to carry the unit on your person.This information is also included in the activ.A.C.¿ therapy system information guide provided to the patient upon delivery of the activ.A.C.¿ therapy system to her home.

Event Description

On (b)(6) 2017, the following information was reported to kci by patient: on (b)(6) 2017, the activ.A.C.¿ therapy (system) carrying case strap allegedly slipped off her shoulder, and the unit fell on her toe and broke it.On (b)(6) 2017, the following information was reported to kci by patient: on (b)(6) 2017, the patient was carrying the unit over one shoulder and it slipped off and fell on her "pinky toe" allegedly breaking it.The patient stated she knows she was not wearing the unit as advised by her nurse, across the body.No additional information is available.A device evaluation of the activ.A.C.¿ therapy (system) is currently pending completion.

Manufacturer Narrative

Based on the additional information obtained regarding the device, kci's assessment remains the same; this report is being filed due to possible use error.

Event Description

On 09 may 2017, the device was tested per quality control (qc) procedure by kci field service, and the unit passed the qc checks and met specifications.On 22 may 2017, the device was placed with the patient.On 17 jul 2017, the device was tested per quality control (qc) procedure by kci quality engineering, and the unit passed the qc checks.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.

• Brand Name: ACTIV.A.C.¿ THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KCI USA, INC.; san antonio TX
• Manufacturer Contact: paul arrendell ; 6203 farinon drive; san antonio, TX 78249 ; 2105154108
• MDR Report Key: 6725649
• MDR Text Key: 80474074
• Report Number: 3009897021-2017-00083
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083357
• 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: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDACT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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): Other
• Patient Age: 47 YR
• Patient Weight: 57