PILLOW, GENTLETOUCH, 7 INCH RT 1937Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00842430101748), received between May 31, 2019 and Jul 18, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DEEP TISSUE INJURY ON FOREHEAD USING GENTLETOUCH PILLOW DURING 8+ HOUR PROCEDURE.

  Patient problems: Erythema; Unspecified Tissue Injury

  MAUDE report 17344729 ↗
• InjuryMay 3, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT GOT INJURED DUE TO THE USE OF PATIENT SUPPORT PILLOW DURING THE SURGERY.

  Patient problems: Blister; Erythema; Rash

  MAUDE report 16865778 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FOLLOWING A FIVE HOUR PRONE SPINAL SURGERY, THE PATIENT HAD REDNESS ON FOREHEAD AND CHIN. SUBSEQUENTLY BLISTERS DEVELOPED AND LEAKED SEROSANGUINOUS FLUID. A WOUND CONSULT WAS ORDERED, TRIPLE OINTMENT WAS APPLIED, AND VASELINE DRESSINGS WERE USED.

  Patient problems: Blister; Erythema; Ulcer

  MAUDE report 12366583 ↗
• InjuryMay 18, 2021Patient Device Interaction Problem; Patient Device Interaction 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.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11841690 ↗
• InjuryJan 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FACILITY REPORTED A DEEP TISSUE INJURY ON THE PATIENT'S CHIN. THIS IS PATIENT 3 OF 3 REPORTED BY THE SAME FACILITY. THIS 7-INCH PILLOW WAS DESCRIBED AS HIGHER AND HARDER THAN THE PREFERRED PILLOW AND IT WAS REPORTED THAT IT HAD NO SPACE FOR THE ENDOTRACHEAL TUBE AND/OR SUCTION. THE PILLOW WAS REPORTEDLY TRIMMED IN SOME WAY IN AN ATTEMPT TO REDUCE THE PRESSURE ON THE FACE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11207641 ↗
• InjuryJan 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FACILITY REPORTED A DEEP TISSUE INJURY ON THE PATIENT'S CHIN. THIS IS PATIENT 1 OF 3 REPORTED BY THE SAME FACILITY. THIS 7-INCH PILLOW WAS DESCRIBED AS HIGHER AND HARDER THAN THE PREFERRED PILLOW AND IT WAS REPORTED THAT IT HAD NO SPACE FOR THE ENDOTRACHEAL TUBE AND/OR SUCTION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11207576 ↗
• InjuryJan 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FACILITY REPORTED A DEEP TISSUE INJURY ON THE PATIENT'S CHIN. THIS IS PATIENT 1 OF 3 REPORTED BY THE SAME FACILITY. THIS 7-INCH PILLOW WAS DESCRIBED AS HIGHER AND HARDER THAN THE PREFERRED PILLOW AND IT WAS REPORTED THAT IT HAD NO SPACE FOR THE ENDOTRACHEAL TUBE AND/OR SUCTION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11207537 ↗
• InjuryDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY A FAMILY MEMBER THAT A PATIENT WAS BURNED ON THE FOREHEAD AND CHIN DURING SURGERY, CAUSED BY USE OF THE FACE PILLOW.

  Patient problems: Burn(s); Erythema; Scarring

  MAUDE report 9512869 ↗
• InjuryOct 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE HOSPITAL HAS HAD SOME FACIAL INJURIES WITH THE USE OF THE HEADREST PILLOWS.

  Patient problems: Injury

  MAUDE report 9204065 ↗
• InjuryMay 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD PRESSURE SORE TO LEFT SIDE OF CHIN FOLLOWING PROCEDURE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 8659827 ↗
• InjuryMay 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD PRESSURE SORE TO FOREHEAD AFTER PROCEDURE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 8659687 ↗