MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION - COLD SPRINGS DEPEND; GARMENT, PROTECTIVE, FOR INCONTINENCE

Model Number WOMEN LARGE MAXIMUM

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

Patient Problems Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and records can be performed.Complaints which are serious in nature are reviewed on a regular basis or for due cause to provide visibility and escalation.In addition, complaints are also monitored for trending on a monthly cadence.No further information is available at this time.

Event Description

Consumer reported that her foot got caught in product while putting it on.She then slipped and dislocated her left shoulder and had 2 compression fractures in her spine.She was then taken by ambulance to the hospital and admitted on (b)(6) 2017 when shoulder surgery was performed.Since (b)(6) 2017, she has had multiple hospital visits.She was treated with morphine for pain.She continues to have pain and is going to chiropractor and physical therapy.

• Brand Name: DEPEND
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION - COLD SPRINGS; 1050 cold springs rd.; neenah WI 54956
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION - COLD SPRINGS; 1050 cold springs rd.; neenah WI 54956
• Manufacturer Contact: marian vargas ; 2100 winchester road; neenah, WI 54956 ; 9207215889
• MDR Report Key: 8094063
• MDR Text Key: 128019463
• Report Number: 2184163-2018-00004
• Device Sequence Number: 1
• Product Code: EYQ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/21/2018

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 Model Number: WOMEN LARGE MAXIMUM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/21/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR