MAUDE Adverse Event Report: KULZER FLEXITIME LIGHT FLOW; IMPRESSION MATERIAL

Catalog Number 40005040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

9/14/2020 - sent email response with dr.(b)(6) stating that our material is not radiopaque and that i would be following up the next day.9/15/2020 - left message with office asking for dr.(b)(6) to call back regarding patient who swallowed impression material.9/15/2020 - dr.(b)(6) called from (b)(6) location, where the incident took place.Dr.(b)(6) let me know they were using flexitime light flow as a wash in denture and the patient (female) gagged and they immediately gave her suction, but the patient felt that she had swallowed some.They did not see if some was actually swallowed as they suctioned out the material.They were worried about a possible bowel blockage and the patient went to the er right after the appointment.Xrays were taken and examination performed and nothing was seen on the xray.I did let doctor know our impression material does not have radio-opacity and that an xray would likely not show swallowed material.She said they took some of the material and let it set and then took an xray of it and it showed up.I explained that we would still stand by that it is not radiopaque and would not show up on xray.The patient was discharged and the radiologist called and spoke with dr.D stating everything seemed ok.They will follow up with patient and i will follow up with them in a week.I did recommend for them to contact patient regularly to see if any digestive problems arise, gastric discomfort, acid reflux, and to check stool for colored content.9/22/2020 - spoke with front office who stated they checked in with patient and she is feeling fine.She had what she described as cramping a couple days after the incident, but had a bowel movement and after that she felt normal and has felt fine since.She did not see any foreign material or abnormal color in her stool.Office staff stated they did not receive any paperwork from hospital or patient, just verbal phone conversation the doctor had with the radiologist.

Event Description

Patient gagged while having a procedure done and accidentally swallowed a small amount of impression material.

• Brand Name: FLEXITIME LIGHT FLOW
• Type of Device: IMPRESSION MATERIAL
• Manufacturer (Section D): KULZER; dietrich honold nr. 1; sacalaz 30737 0; RO 307370
• MDR Report Key: 10652576
• MDR Text Key: 210645993
• Report Number: 1821514-2020-00005
• 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: Dentist
• Type of Report: Initial
• Report Date: 10/09/2020,10/08/2020

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: Health Professional
• Device Catalogue Number: 40005040
• Device Lot Number: K010115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/14/2020
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other