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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POLIURETANOS, S.A. DE C.V. DRIVE; PRESSURE REDISTRIBUTION FOAM MATTRESS
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POLIURETANOS, S.A. DE C.V. DRIVE; PRESSURE REDISTRIBUTION FOAM MATTRESS Back to Search Results
Model Number 6500-DE-2-FB
Device Problem Pressure Problem (3012)
Patient Problem Ulcer (2274)
Event Date 05/03/2022
Event Type  No Answer Provided  
Event Description
Drive devilbiss healthcare was contacted regarding a reported injury involving a pressure redistribution foam mattress, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user, who is bedridden, reported having developed bed sores after 8 months of use, reportedly due to the mattress becoming very hot.Drive did not receive any information regarding the patient's overall pressure injury management program.Drive is currently investigating the incident, including attempting to retrieve the product to evaluate it.Drive will update this filing if additional information becomes available.
 
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Brand Name
DRIVE
Type of Device
PRESSURE REDISTRIBUTION FOAM MATTRESS
Manufacturer (Section D)
POLIURETANOS, S.A. DE C.V.
alfredo nobel s/n
zona industrial
toluca 50010
MX  50010
MDR Report Key15015277
MDR Text Key295889019
Report Number2438477-2022-00065
Device Sequence Number1
Product Code IKY
UDI-Device Identifier00822383516431
UDI-Public822383516431
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model Number6500-DE-2-FB
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/14/2022
Event Location Home
Date Report to Manufacturer07/15/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/14/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient SexFemale
Patient Weight147 KG
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