MAUDE Adverse Event Report: SHANDONG HUGE DENTAL MATERIAL CORPORATION IMPRESSION MATERIAL; MATERIAL, IMPRESSION

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

Since medical intervention was required to preclude a serious injury, this event is reportable per 21 cfr part 803.

Event Description

Customer got impressions stuck in mouth and had to go to two different hospitals and dentist to get impression mold unstuck.Patient was also treated in the hospital for shock and anxiety due to the incident.

• Brand Name: IMPRESSION MATERIAL
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): SHANDONG HUGE DENTAL MATERIAL CORPORATION; no. 68 shanhai road; donggang district; rizhao shandong, 27680 0; CH 276800
• MDR Report Key: 14136347
• MDR Text Key: 289447306
• Report Number: 3014845255-2022-00003
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2022

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 Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/18/2022
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female