FLEXITIME CORRECT FLOW 50034806

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-11 for FLEXITIME CORRECT FLOW 50034806 manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[16219624] Pt called asking for info on the flexitime correct flow. She said that she collapsed soon after its use. Asked for the dentist info. She said she was going to call the office and have them call us. On (b)(6) 2013, spoke to receptionist. She said the pt was having nightguards made. She said that the pt had one of the two impressions taken and then stepped out with her husband to get air. Discussed that pt had stated she collapsed. She said she did not see the pt collapse. She said that she came back in and they did the second impression. She did not know what happened. She said that they have used vps impression material on her before and there was no problem that time. On (b)(6) 2013, dental assistant called from the office. She stated that they did a two-step putty/wash impression on the maxillary using ft putty in pt's mouth for one min then ft cf was added for 3 mins in the pt's mouth. When they removed the impression the pt was light headed, weak, thirsty and had trouble walking. The pt was assisted out of the office by her husband and did not return for 15 to 20 mins. The pt wanted to do the mandibular impression. Since there was no trouble when they used just the putty they did the mandibular impression using only the putty for 3 mins. The pt was fine with this impression. The office then did a bite registration impression using star vps material, from a different mfr, this was in for 1 min and the pt was light headed again. The assistant said she did not see the pt collapse nor did the pt report collapsing while outside. The pt's med hx shows allergy to penicillin, cleaning chemicals, and single bond bonding agent. The pt has had anaphylactic reactions to other allergens and has anemia. The pt wears a dental mask when she comes to the office and sometimes brings an air purifier. Offered to send samples and ingredients list for allergy testing. On (b)(6) 2013, spoke to receptionist. She said that pt was supposed to see the allergist last week. She said that she was supposed to call them with info. She said they have not heard from her. She said that assistant would f/u with the pt and call us back. Please refer to mfr report # 9681707-2013-00008.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1925223-2013-00135
• MDR Report Key: 3353311
• Date Received: 2013-09-11
• Date of Report: 2013-08-15
• Date of Event: 2013-08-14
• Date Facility Aware: 2013-08-15
• Date Added to Maude: 2013-09-18
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 4315 SOUTH LAFAYETTE BLVD.
• Manufacturer City: SOUTH BEND IN 466142517
• Manufacturer Country: US
• Manufacturer Postal: 466142517
• Manufacturer G1: HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
• Manufacturer Street: 4315 SOUTH LAFAYETTE BLVD.
• Manufacturer City: SOUTH BEND IN 46614251
• Manufacturer Country: US
• Manufacturer Postal Code: 46614 2517
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FLEXITIME CORRECT FLOW
• Generic Name: ELM MATERIAL, IMPRESSION
• Product Code: ELM
• Date Received: 2013-09-11
• Returned To Mfg: 2013-08-27
• Catalog Number: 50034806
• Lot Number: 390158
• Device Expiration Date: 2016-02-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 1 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HERAEUS KULZER GMBH
• Manufacturer Address: DORMAGEN GM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-09-11