Catalog Number UNK_MED |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
|
Patient Problems
Pressure Sores (2326); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/18/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that a patient received an unstageable pressure injury after staying on an isoflex gel mattress.Attempts are being made to gather more details regarding the injury from the user facility.
|
|
Manufacturer Narrative
|
Upon investigation, it was found this report is a duplicate of mfr report#: 0001831750-2022-00264.Please see mfr report#: 0001831750-2022-00264 for regulatory determination and investigation details.
|
|
Event Description
|
It was reported that a patient received an unstageable pressure injury.Upon investigation, it was found this report is a duplicate of mfr report#: 0001831750-2022-00264.Please see mfr report#: 0001831750-2022-00264 for regulatory determination and investigation details.
|
|
Search Alerts/Recalls
|