FDA Adverse Event Injury Summary report: N

COMPACT WATER BATH

MDR report key: 11029337 · Received December 17, 2020

Report

Report Number: 2939274-2020-05629
Event Type: Injury
Date Received: December 17, 2020
Date of Event: November 19, 2020
Report Date: November 19, 2020
Manufacturer: WRIGHTS LANE SYNTHES USA PRODUCTS LLC
Product Code: JTQ
UDI-DI: 10887587025919
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/ OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2020, A WATER COMPACT BATH DESIGNED FOR REASONABLE FIXATION SYSTEM WAS USED AS FLUID WARMER AND SCALDED THE PATIENT. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) COMPACT WATER BATH. THIS IS REPORT 1 OF 1 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1494514	COMPACT WATER BATH	BATH, INCUBATORS/WATER, ALL	JTQ	WRIGHTS LANE SYNTHES USA PRODUCTS LLC	05.725.010		10887587025919

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention