MAUDE Adverse Event Report: DERMATHERAPY; EXAMINATION, GOWN

Device Problem Use of Device Problem (1670)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

General use patient gown.The product code listed is not correct.This device is not classified as a medical device.This is a general use patient gown.The initial reporter identified this as an examination gown incorrectly.Model #749d6425, lot #cdc010313880.Other - the information supplied on the gown's use does not meet the fda criteria for a reportable event.The patient gown was not directly implicated in the patient burn/blisters, i.E., gown had no contact with affected area.This was confirmed during follow-up discussions with the (6) hosp.On 2/14/2018 standard textile's vice president of quality, spoke directly with (b)(6), risk management specialist, at (b)(6) hospital.She confirmed that the gown in question came from a completed trial from the (b)(6) burn unit and that the gowns were provided, not purchased.When the trial was completed, the gowns were not returned.Ms.(b)(6) believes that these gowns were put into their regular laundry and circulated with the other examination gowns.Subsequently this patient gown was used on the mri patient that had this medical event occur.As this gown has snaps/metal closures on the top/neck, the mri instruction for use preclude metal from being used during the procedure.Ms.Owens did confirm that metal snaps would not be appropriate for an mri procedure.Important note: the snaps on the gown were not in close proximity to the patient burn/blisters and the upper body areas in contact with the snaps were not associated with the burns or blistering.No adverse effects were observed due to the use of this gown even though gowns with metal snaps should not be used in mri's.Our conclusion is that the patient gown was not involved with the burn/blistering reported by the patient.- attachment: (b)(4).

Event Description

Hospital indicated that a patient with right leg edema was undergoing an mri and indicated that she felt something during the scan.The scan was stopped and there were two welts on the insides of her thighs.The patient wanted to proceed with the scan.After the scan was complete, blisters appeared in the area of the welts.The gown and robe she was wearing was not touching the area where the blisters arose.

• Brand Name: DERMATHERAPY
• Type of Device: EXAMINATION, GOWN
• Manufacturer Contact: bradley bushman ; one knollcrest drive; cincinnati, OH 45237 ; 5137619255
• MDR Report Key: 7425294
• MDR Text Key: 105313114
• Report Number: 0001527185-2018-00001
• Device Sequence Number: 1
• Product Code: FME
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1