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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BLKT 1-SIDE NONWOV COLDER CON; SYSTEM, THERMAL REGULATING
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STRYKER MEDICAL-KALAMAZOO BLKT 1-SIDE NONWOV COLDER CON; SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number 8001061610
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Pressure Sores (2326)
Event Date 06/10/2021
Event Type  malfunction  
Event Description
It was reported that a patient sustained a pressure injury from the altrix pad.The user facility also stated that the patient was sitting at a 90 degree angle, which caused the pad on their abdomen to dig into their leg.The treatment and severity of the pressure injury is currently unknown and attempts are being made to gather more information from the user facility.
 
Event Description
It was reported that a patient sustained a pressure injury from the altrix pad.The user facility also stated that the patient was sitting at a 90 degree angle, which caused the pad on their abdomen to dig into their leg.
 
Manufacturer Narrative
It was reported that no treatment was needed for the patient's skin.The customer did not record the lot number and did not require any further action.H3 other text : device not accessible for evaluation.
 
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Brand Name
BLKT 1-SIDE NONWOV COLDER CON
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key12123440
MDR Text Key260131932
Report Number0001831750-2021-00980
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K152266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number8001061610
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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