MAUDE Adverse Event Report: GENTLE TOUCH; FACE PILLOW

Model Number	1937
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported in g.Ibarra, a.Rivera, b.Fernandez-ibarburu et al., prone position pressure sores in the covid-19 pandemic: the madrid experience, journal of plastic, reconstructive & aesthetic surgery, https://doi.Org/10.1016/j.Bjps.2020.12.057.Fifty-seven icu patients treated with invasive mechanical ventilation and prone positioning using gentletouch face pillow developed 136 proning-related pressure injuries, including 11 on foreheads and 22 on chins.Overall, 64% were reported as stage ii and 28% as stage i.Significant differences between patients with and without pronation injuries include days of pronation therapy (average 13 vs 8), pronation sessions lasting more than 24 hours (51% vs 18%), and prealbumin levels (24 vs 35 mg/dl).Difficulty following the positioning protocol was reported due to staff shortage and overwhelming numbers of patients.In the patients who survived, the wounds healed successfully, although with scarring, hypo- and hyper-pigmentation, and permanent hair loss in eyebrow and beard areas.
Additional Manufacturer Narrative
As described in the article, multiple factors likely contributed to the injuries, including the disease itself and the patients' very high risk braden scores.It is unknown how frequently the face pillows were changed or the head positioning monitored and adjusted.As described in the article, the staff shortages, undertrained volunteers, and difficult working conditions may have led to less than ideal care.
Event or Problem Description
Reported in g.Ibarra, a.Rivera, b.Fernandez-ibarburu et al., prone position pressure sores in the covid-19 pandemic: the madrid experience, journal of plastic, reconstructive & aesthetic surgery, https://doi.Org/10.1016/j.Bjps.2020.12.057.Fifty-seven icu patients treated with invasive mechanical ventilation and prone positioning using gentletouch face pillow developed 136 proning-related pressure injuries, including 11 on foreheads and 22 on chins.Overall, 64% were reported as stage ii and 28% as stage i.Significant differences between patients with and without pronation injuries include days of pronation therapy (average 13 vs 8), pronation sessions lasting more than 24 hours (51% vs 18%), and prealbumin levels (24 vs 35 mg/dl).Difficulty following the positioning protocol was reported due to staff shortage and overwhelming numbers of patients.In the patients who survived, the wounds healed successfully, although with scarring, hypo- and hyper-pigmentation, and permanent hair loss in eyebrow and beard areas.

• Brand Name: GENTLE TOUCH
• Common Device Name: FACE PILLOW
• MDR Report Key: 11841690
• Report Number: 2921578-2021-00016
• Device Sequence Number: 4662904
• Product Code: CCX
• UDI-Device Identifier: 00842430101748
• UDI-Public: 00842430101748
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1937
• Device Catalogue Number: 1937
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 08/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 85