MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-04-12 for DERMATHERAPY manufactured by .
[105313114]
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)
Patient Sequence No: 1, Text Type: N, H10
[105313115]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001527185-2018-00001 |
| MDR Report Key | 7425294 |
| Report Source | OTHER |
| Date Received | 2018-04-12 |
| Date Mfgr Received | 2018-02-12 |
| Device Manufacturer Date | 2016-11-12 |
| Date Added to Maude | 2018-04-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRADLEY BUSHMAN |
| Manufacturer Street | ONE KNOLLCREST DRIVE |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5137619255 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DERMATHERAPY |
| Generic Name | EXAMINATION, GOWN |
| Product Code | FME |
| Date Received | 2018-04-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-12 |