MAUDE Adverse Event Report: KULZER,LLC FLEXITIME MONOPHASE; MATERIAL, IMPRESSION

Catalog Number 66035993

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abdominal Pain (1685)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

As allowed by exemption (b)(4), (b)(4) is submitting the report on behalf of kulzer srl (the manufacturer).Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.The 510k entry is for flextime, with the first "i" missing.This is the same product, with two diffrent spellings.The device has not been returned for evaluation, but images of the artifact removed from the patient have been examined.The mass appears to consist of flexitime monophase.The dfu, page 20, states: do not swallow and ingest.If health problems arise after swallowing impression material, seek medical attention immediately.Intestinal blockage may arise in rare cases.

Event Description

Patient had impression taken on (b)(6) 2017 using flexitime monophase.She swallowed some impression material, which created an intestinal blockage.Five months later, on (b)(6) 2017 she required surgery to remove the blockage.

• Brand Name: FLEXITIME MONOPHASE
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): KULZER,LLC; claderia c3; dietrch honold 1; sacalaz-judetul, timis 30737 0; RO 307370
• Manufacturer (Section G): KULZER,LLC; claderia c3; dietrch honold 1; sacalaz-judetul, timis 30737 0; RO 307370
• Manufacturer Contact: rita rogers ; 4315 lafayette blvd; south bend, IN 46614
• MDR Report Key: 6937308
• MDR Text Key: 89184469
• Report Number: 3011203516-2017-00005
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K000629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 66035993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 39 YR