Progressa® Surface P7520A7Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887761999626), received between Apr 8, 2021 and Apr 9, 2021 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED BEDSORE ISSUES AT (B)(6) HOSPITAL, IN THE INTENSIVE CARE UNIT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STAGE 3 PRESSURE ULCER THAT WAS 15 CM WITH FIBRINOUS TISSUE PRESENT. NO INTERVENTION WAS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11641133 ↗
• DeathApr 9, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED EIGHT PATIENT INJURIES TO HILLROM. THREE OF THESE INJURIES WERE ASSESSED TO BE SERIOUS AND THEREFORE REPORTABLE ADVERSE EVENTS (HILLROM REFERENCE NUMBERS: (B)(4), (B)(4) AND (B)(4)). FIVE OF THE PATIENT INJURIES WERE ASSESSED AS MINOR INJURIES AND THEREFORE NOT REPORTABLE. ADDITIONAL INFORMATION OBTAINED ON 23/MARCH/2021 REPORTED THAT THERE WAS A PATIENT WHO EXPERIENCED HEMORRHAGIC SHOCK, COVID-19 INFECTION, AND DEATH. THE EXACT SEQUENCE OF EVENTS IS UNKNOWN, AS WELL AS WHAT ROLE THE DEVICE OR SURFACE PLAYED IN THE PATIENT'S DEATH. THE CUSTOMER WAS UNABLE TO CONFIRM WHICH OF THE 8 PATIENTS WITH REPORTED INJURIES HAD SUFFERED THE HEMORRHAGIC SHOCK, COVID-19 AND EXPIRED. IN THE ABSENCE OF CLEAR INFORMATION THIS REPORT IS BEING SUBMITTED AS A SEPARATE INCIDENT REPORT.

  Patient problems: Hypovolemic Shock; Pressure Sore/Ulcer

  MAUDE report 11641132 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THAT THE PATIENT HAD A STAGE 2/3 SACRUM BEDSORE WITH 8 CM DIAMETER. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS PATIENT INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11636238 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THAT THE PATIENT HAD A STAGE ¾ SACRUM BEDSORE NECROSIS WITH 5 CM DIAMETER; KNEE AND CHIN BEDSORES FOLLOWING VENTRAL DECUBITUS. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS PATIENT INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11636198 ↗