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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; PACK, HOT OR COLD, WATER CIRCULATING
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STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; PACK, HOT OR COLD, WATER CIRCULATING Back to Search Results
Catalog Number UNK_MED
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Erythema (1840); Irritation (1941)
Event Date 09/08/2017
Event Type  malfunction  
Event Description
It was alleged that the patient was laying on a pad on their side while sleeping and it was believed that the therapy pad was used through the night.The patient alleged red marks and irritation after use.It was identified that the patient was not monitored and the hospital did not follow their own policy of using a pillow case over the pad and monitoring skin condition.It was reported that the red marks may have been attributed to laying on the pad for an extended period of time and was not identified to be a burn.There was no treatment given to the patient for the red marks.
 
Manufacturer Narrative
After investigation, the alleged event was that a patient had developed a pressure injury following application of a mul-t-pad but no medical intervention or treatment was required and no alleged component level issue was alleged with the device.The patient had been using the therapy pad without medical supervision overnight and the account had stated that they were not following their own policy of using a pillow case over the pad and monitoring skin condition.
 
Event Description
It was alleged that the patient was laying on a pad on their side while sleeping and it was believed that the therapy pad was used through the night.The patient alleged red marks and irritation after use.It was identified that the patient was not monitored and the hospital did not follow their own policy of using a pillow case over the pad and monitoring skin condition.It was reported that the red marks may have been attributed to laying on the pad for an extended period of time and was not identified to be a burn.There was no treatment given to the patient for the red marks.
 
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Brand Name
UNKNOWN_MEDICAL_PRODUCT
Type of Device
PACK, HOT OR COLD, WATER CIRCULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6938340
MDR Text Key89633469
Report Number0001831750-2017-00443
Device Sequence Number1
Product Code ILO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_MED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/12/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/17/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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