GENTLE TOUCH
Received May 18, 2021 · Event occurred May 1, 2020
Report 2921578-2021-00016 · MDR key 11841690
Device
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
61 YR
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
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.
Description of Event or Problem
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.
Description of Event or Problem
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.