MAUDE Adverse Event Report: KULZER PROVIL NOVO; IMPRESSION MATERIAL

Catalog Number 65209225

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

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

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020 - she swallowed 1-2ml of the uncured provil novo light.She has no symptoms.Details: patient is in their 70s.Woman.Occurred while taking an impression using provil novo l.Patient's subjective symptom = no particular.Amount swallowed = very small amount (1 ~ 2ml).The impression material flowed a little in an uncured state, but the process was completed successfully.Explained that "if swallowed, see a doctor and may cause intestinal obstruction." since the amount swallowed is extremely small, it is highly likely that it will be excreted as stool, but we cannot diagnose it, so we asked for follow-up.The next medical examination day will be wednesday, (b)(6).Since there are no symptoms at the moment (and probably no new symptoms in the future), i will only report this case.10/22/2020 - dear (b)(6), thank you for introducing the complaint to gnm.May i kindly ask you to keep me updated, when you receive any new information about the patient's health status or probably when they will let you know that the material has left the body? one question for my understanding.You are not going to report this event to the mhlw/pmda as long as no symptoms occur.Is this correct? thank you for your kind support.Best regards, (b)(6).10/22/2020 - dear (b)(6) thank you for reply.As you requested, i will contact you as soon as we receive any new information about the patient.Also, as you said, there is no need to report this case to mhlw/pdma as it has not affected human health.Thank you for your cooperation.(b)(6).10/23/2020 - dear mrs.(b)(6), sorry for answering late, i was quite busy during the last days and i saw no danger in delay so far.1 to 2 ml of swallowed material is a quite small amount.Very probably, there is no real danger ahead according to my experience.Those amounts might be swallowed more or less daily and are assumedly the size of a pea or peanut.They could make issues, but it is very unlikely.It is important to follow-up with the dentist or clinic that they have reasonable contacts to the patient asking for digesting problems, like heartburn, gastric pressure, malaise after eating, stomach cramps or similar problems with the gastrointestinal tract.This is just for prevention.And there should be an advice that the patient should inspect her stool for the intensively colored impression materials somewhere.I know it is not the common way to inspect its own stool, nevertheless, you should recommend.If there are any signs of disorder it is recommended that the patient sees a clinic for intestinal issues which might have a look with gastroscopy or colonoscopy into the patient.This is quite less harmful than finally have a surgery of the intestine.Very probably, and i cross my finger, it will be a harmless issue.In most of those cases it is no issues, except for the very rare cases you mentioned below.Good luck and please keep us informed on any information or development.I hope my advice could help you to stay the case for kjp? best regards, (b)(6).11/10/2020 - dear (b)(6), time passes so quickly.May i ask you for an update? " did the material leave the patient? " did the patient seek for further medical help - like a family practitioner? although you do not have to report to mhlw/pmda our american colleagues have to evaluate this complaint, too.They have to decide whether this event is reportable to the fda or not.Thank you for your kind support.Warm regards, (b)(6).11/10/2020 - dear (b)(6), really sorry for not replying soon." did the material leave the patient? nobody knows whether the impression has left the patient or not." did the patient seek for further medical help - like a family practitioner? none.Here is the revised word file.Hope the information could be of help to american colleagues.Warm regards, (b)(6).

Event Description

Patient swallowed 1-2ml of impression material.

• Brand Name: PROVIL NOVO
• Type of Device: IMPRESSION MATERIAL
• Manufacturer (Section D): KULZER; dietrich honold nr. 1; sacalaz, 30737 0; RO 307370
• MDR Report Key: 10867757
• MDR Text Key: 217118853
• Report Number: 1821514-2020-00007
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 11/16/2020,11/13/2020

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: 65209225
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2020
• Event Location: Other
• Date Report to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR