MAUDE Adverse Event Report: INTEGRA PAIN MANAGEMENT HITH KIT; N/A

Catalog Number INSHITH

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

Inshith hith (kit) was returned for evaluation: device history record (dhr): a dhr review of lot 6788598 was performed.The lot had no documented issues during production and passed final inspection before shipping without any indication of wetness or discoloration.There is nothing to suggest that the product was wet before leaving the manufacturer's site.Failure analysis - the product was returned for evaluation; however, as several photographs were taken prior to shipping, the physical sample was not required to respond to this complaint.The photographs revealed three items and the shipper box they were contained in to be so saturated that the cardboard had begun to warp and bend.As water tends to dry if left in ventilated areas at moderate temperatures, it is not surprising by an inability to detect wetness when the product was returned, though the water damage/discoloration was evident in the photos.The manufacturer's warehouse does not have a record of water leaks impacting the roof or affecting product during the time of manufacture and shipping.However it is possible that the chosen shipping company used to move the product did not adequately protect the product during transit if there was rain.Root cause - the product was damaged after leaving this site.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

A facility reported that the hith kit (inshith) was wet and discolored upon arrival to the facility.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

This mdr is being submitted for correction of an error which was submitted in the initial mdr."device available for evaluation" should have read "returned to manufacturer.".

• Brand Name: HITH KIT
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA PAIN MANAGEMENT; 3395 west 1820 south; 3395 west 1820 south; salt lake city UT
• Manufacturer (Section G): INTEGRA PAIN MANAGEMENT; 3395 west 1820 south; salt lake city UT
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17251674
• MDR Text Key: 318389568
• Report Number: 1722447-2023-00001
• Device Sequence Number: 1
• Product Code: HBG
• Combination Product (y/n): N
• PMA/PMN Number: K961113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INSHITH
• Device Lot Number: 6788598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1