MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PROTECTOR, HEEL, HEEL RAISER ULTRA

Catalog Number MDT82705CS

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Tissue Damage (2104)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the heel raiser ultra heel protector's "velcro was too low" and the "straps were never adjusted" which made the boot too tight in the toes/bunion area.Per report, the patient wore the heel protector since (b)(6) 2019 and on (b)(6) 2019, patient developed deep tissue injury to the right first metatarsal/bunion measuring 1x2cm.After this incident, the patient's feet were offloaded on two pillows and optifoam dressing was reportedly applied.Due to the reported deep tissue injury and the required medical intervention, this medwatch is being filed.The sample is not available to be returned for evaluation.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the heel protector was too tight resulting in the patient developing deep tissue injury to the right first metatarsal/bunion.

• Type of Device: PROTECTOR, HEEL, HEEL RAISER ULTRA
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8688902
• MDR Text Key: 147890069
• Report Number: 1417592-2019-00090
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDT82705CS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 86