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

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.

• 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 Key: 15839947
• MDR Text Key: 304091988
• Report Number: 3003312341-2022-00004
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101705
• Number of Events Reported: 1
• 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 Number: MA2260-PM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 12/20/2022
• 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 Number: 1
• Patient Outcome(s): Other