MAUDE Adverse Event Report: EMPI, INC HYBRESIS

Model Number 199589-001

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/20/2014

Event Type  Injury  

Event Description

It was reported to empi that a patient received a 3rd degree burn during a hybresis treatment.The injury was on the anterior left shoulder, the diagnosis was s/p rtc repair; biceps tendonitis.This was the 2nd treatment.The skin was cleaned with alcohol prior to the treatment.The compound used was dexamethasone at 0.4% concentration and 1.5ml was used on the negative side of the hybresis patch.The mode was hybresis and the treatment was for 2 hours for 80ma minute.The therapy performed prior to the treatment was, therapeutic excercise, manual therapy to include soft tissue, joint mobilization and prom (passive range of motion).The treatment area was not compressed and there was no wrap or covering on the electrode.The patient noticed the burn upon removal of the patch and the physical therapist was notified.The burn was under the negative side of the patch.There was discomfort, pain and redness around the area of the burn.The patient did not receive medical treatment for the incident.Progress toward recovery was not impeded because of this incident.The patient has not experienced this type of issue with the hybresis patch before.

Manufacturer Narrative

The hybresis patch that was used will not be returned for evaluation.If more information becomes available then a follow-up report will be filed.Patch was discarded by patient.

• Brand Name: HYBRESIS
• Type of Device: HYBRESIS
• Manufacturer (Section D): EMPI, INC; 205 hwy 22 east; clear lake SD 57226
• Manufacturer (Section G): EMPI, INC; 205 hwy 22 east; clear lake SD 57226
• Manufacturer Contact: debbie miranda ; 205 hwy 22 east; clear lake, SD 57226 ; 6058747057
• MDR Report Key: 3786448
• MDR Text Key: 4361489
• Report Number: 1721293-2014-00004
• Device Sequence Number: 1
• Product Code: EGJ
• Combination Product (y/n): N
• PMA/PMN Number: K072946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physical Therapist
• Device Expiration Date: 07/01/2015
• Device Model Number: 199589-001
• Device Lot Number: 93821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2014
• 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): Other
• Patient Age: 60 YR