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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TSCI BV DBA THE 37COMPANY UPPER BODY PLUS BOX OF 40; SYSTEM, THERMAL REGULATING

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TSCI BV DBA THE 37COMPANY UPPER BODY PLUS BOX OF 40; SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number MA2260-PM
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Skin Tears (2516)
Event Date 09/22/2022
Event Type  malfunction  
Event Description
It was alleged that, at the end of the surgical procedure (about 2 hours), the upper body warmer was taken off of the patient who was prone.As the warmer was removed, it was noticed that a lot of the drape where the adhesive was, was sticking to the patient.When clinical staff attempted to remove part of the drape that was stuck onto the patient (the adhesive part), the patients¿ skin came off.
 
Event Description
It was alleged that, at the end of the surgical procedure (about 2 hours), the upper body warmer was taken off of the patient who was prone.As the warmer was removed, it was noticed that a lot of the drape where the adhesive was, was sticking to the patient.When clinical staff attempted to remove part of the drape that was stuck onto the patient (the adhesive part), the patients¿ skin came off.
 
Manufacturer Narrative
Multiple attempts were made to contact this customer to obtain further information, however, no response was received.A review of previous similar complaints identified that this issue may have been due to a pre-existing skin condition which could result in a reaction to an adhesive applied to the skin, however this could not be confirmed.A stryker sr.Staff medical science liaison reviewed the information and stated that based on the event description the patient may have received over the counter medication and the injury was likely bandaged.H3 other text : device was not accessible for testing.
 
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Brand Name
UPPER BODY PLUS BOX OF 40
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
TSCI BV DBA THE 37COMPANY
beeldschermweg 6f
ah amersfoort 03821
NL  03821
Manufacturer (Section G)
TSCI BV DBA THE 37COMPANY
beeldschermweg 6f
ah amersfoort 03821
NL   03821
Manufacturer Contact
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key15839947
MDR Text Key304091988
Report Number3003312341-2022-00004
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101705
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 12/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Catalogue NumberMA2260-PM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/27/2022
Initial Date FDA Received11/21/2022
Supplement Dates Manufacturer Received10/27/2022
Supplement Dates FDA Received12/20/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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