MAUDE Adverse Event Report: KULZER GMBH GLUMA DESENSITIZER

Catalog Number 66003764

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Edema (1820)

Event Type  Injury  

Manufacturer Narrative

The directions for use state, "protect mucous membranes by using a rubber dam".Even though this is clearly the result of user error, the treating dds had the patient stop his medication after consulting with the patient's physician for a week and had him under observation following antibiotics to prevent super infection.(b)(4).This single mdr will satisfy the reporting obligation for both firms under 21 cfr parts 803.40, 803.42, 803.50(a)(1), 803.50(a)(2) and 803.52.

Event Description

Dentist had a case of patient presenting with dentine sensitivity and "recommend" the use of gluma desensitizer.But while handling the gluma in the oral cavity the patient spread the gluma placed "through" his tongue all over his cheek and palate.He was drinking lukewarm water for the past day and had slight discomfort earlier.He reported after 24 hours with widespread firm swelling.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: DESENSITIZER
• Manufacturer (Section D): KULZER GMBH; philipp-reis-strabe 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer (Section G): KULZER, LLC; 4315 s. lafayette blvd; south bend IN 46614
• Manufacturer Contact: amber brown ; 4315 s. lafayette blvd; south bend, IN 46614 ; 5472995411
• MDR Report Key: 8174683
• MDR Text Key: 130674598
• Report Number: 9610902-2018-00006
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K962812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66003764
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/19/2018
• Event Location: Other
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention