MAUDE Adverse Event Report: HQ, INC. TEMP SENSOR 26K15VSOHC038075; TEMPERATURE SENSOR

Model Number HT150002

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 06/09/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, hq, inc.Received a phone call and e-mail from the principal investigator.During the conversation, the principal investigator stated one of his subjects was scheduled for surgery that afternoon to remove a core temperature pill lodged in his small bowel.Hq, inc.Manufactures the cortemp ingestible temperature sensor.Surgery was completed on (b)(6) 2015.Hq, inc.Has requested, but has not received information from the surgeon.As hq, inc.Receives additional information, we will provide updated reports.

Manufacturer Narrative

On (b)(6) 2015, hq, inc.Received a phone call and email from dr.(b)(6), requesting (b)(4) hq.Inc., to contact him.During the conversation, dr.(b)(6) stated one of his subjects was scheduled for surgery that afternoon to remove a core temperature pill lodged in his small bowel.Hq, inc.Manufactures the cortemp ingestible temperature sensor.(b)(4) called dr.(b)(6) the afternoon of (b)(6) 2015.Dr.(b)(6) recounted the following events orally: according to medical history received and reviewed, the subject had no history of medical issues, but after the trial candidate (subject) was approved and complications resulted, the research team had recently learned the subject's mother has crohn's disease.The subject did not put this information under the family history section of the medical questionnaire given to him before he entered the trial.Crohn's disease is one of the ingestible core body temperature sensors contraindication.

• Brand Name: TEMP SENSOR 26K15VSOHC038075
• Type of Device: TEMPERATURE SENSOR
• Manufacturer (Section D): HQ, INC.; 210 9th st. drive west; palmetto FL 34221
• Manufacturer Contact: william hicks ; 210 9th st. drive west; palmetto, FL 34221 ; 9417234198
• MDR Report Key: 4904973
• MDR Text Key: 6023719
• Report Number: 1038689-2015-00001
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: HT150002
• Device Catalogue Number: HT150002
• Device Lot Number: H081814001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 21 YR