MAUDE Adverse Event Report: HAYWOOD VOCATIONAL OPPORTUNITIES INTRATEMP THERMABASIN DRAPE; FLUID WARMING & SLUSH DRAPES

Model Number ITB100

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2019

Event Type  malfunction  

Event Description

It was reported that prior to use, a hole was observed in the corner of two drapes.There was no hole on the outside of packaging.No patient complications have been reported as a result of this event.

• Brand Name: INTRATEMP THERMABASIN DRAPE
• Type of Device: FLUID WARMING & SLUSH DRAPES
• Manufacturer (Section D): HAYWOOD VOCATIONAL OPPORTUNITIES; 172 riverbend st.; waynesville NC 28786
• Manufacturer (Section G): ECOLAB; 1 ecolab place; st paul MN 55102
• Manufacturer Contact: anuli okolo-young ; 1 ecolab place; st paul, MN 55102 ; 6512502237
• MDR Report Key: 8831335
• MDR Text Key: 213482483
• Report Number: 1043549-2019-40002
• Device Sequence Number: 1
• Product Code: LHC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: ITB100
• Device Lot Number: 79059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1