Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONAIR CORPORATION CONAIR; HEATING PAD Back to Search Results
Model Number HP15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 04/01/2021
Event Type  Injury  
Event Description
On (b)(6) 2022,the incident occurred on (b)(6) 2021 but the claim wasn't reported until (b)(6) 2021.The consumer claims she received a burn on her upper buttocks while in use of the product.The consumer received medical attention.
 
Manufacturer Narrative
On (b)(6) 2022 we have requested the device be returned to the manufacturer for an investigation.To date we have not received the device.
 
Manufacturer Narrative
01/18/2022 - we have requested the device be returned to the manufacturer for an investigation.To date we have not received the device.6/2/2022 - the consumer returned the device to the manufacturer and has been evaluated.Below is the manufacturers narrative: manufacturers narrative: product was returned in good working condition 4/18/2022.Unit was run per ul130.Temperature never exceeded 55c ( 131 f).Ul's limit is 70 c and conairs limit is 60c.We are under both the safety lab's and conairs temperature limits.Unit is not longer manufactured at this vendor.New construction was implemented in 2018.This construction is no longer manufactured.
 
Event Description
1/12/2022 - the incident occurred on (b)(6) 2021 but the claim wasnn't reported until (b)(6) 2021.The consumer claims she received a burn on her upper buttocks while in use of the product.The consumer received medical attention.
 
Manufacturer Narrative
01/18/2022 - we have requested the device be returned to the manufacturer for an investigation.To date we have not received the device.6/2/2022 - the consumer returned the device to the manufacturer and has been evaluated.Below is the manufacturers narrative: 07/06/2022 - there was confusion between consumer complaints.Therefore the orginal manufacturers narrative was incorrect.Below is the corrected manufacturers narrative: manufacturers narrative: unit was run per ul130.Temperature never exceeded 55c ( 131 f).Ul's limit is 70 c and conairs limit is 60c.We are under both the safety lab's and conairs temperature limits.Per attached ib, skin sensitivity varies and the consumers are advised to check skin frequently to avoid burns.We provide one of the lowest temperatures offered by heating pad manufacturers.As stated, temperatures did not rise above 55c (131 f).Unit is not longer manufactured at this vendor.New construction was implemented in 2018.This construction is no longer manufactured.
 
Event Description
1/12/2022 - the incident occurred on 4/1/2021 but the claim wasnn't reported until 12/28/2021.The consumer claims she received a burn on her upper buttocks while in use of the product.The consumer received medical attention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONAIR
Type of Device
HEATING PAD
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd.
stamford CT 06902
Manufacturer Contact
1 cummings point rd.
stamford, CT 06902
MDR Report Key13278656
MDR Text Key283951205
Report Number1222304-2021-00042
Device Sequence Number1
Product Code IRT
UDI-Device Identifier74108104670
UDI-Public74108104670
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 12/28/2021
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? No
Device Model NumberHP15
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/18/2022
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received06/02/2022
07/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-