MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL UNK MAILLEFER; GUTTA-PERCHA

Catalog Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Insufficient Information (4580)

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported that a patient experienced a reaction to the use of gutta-percha points.

Manufacturer Narrative

While it may be possible that this malfunction could result in a serious injury should it recur.Therefore, this event meets the criteria for a reportable event per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Manufacturer Narrative

While it may be possible that this malfunction could result in a serious injury should it recur.Therefore, this event meets the criteria for a reportable event per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

It was reported that a patient experienced a reaction to the use of gutta-percha points.

Manufacturer Narrative

Product has not been returned.Lot# is not correct so no dhr review possible.Root causes are not identified.

• Brand Name: UNK MAILLEFER
• Type of Device: GUTTA-PERCHA
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401
• MDR Report Key: 13171459
• MDR Text Key: 285554942
• Report Number: 8031010-2022-00410
• Device Sequence Number: 1
• Product Code: EKM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 190801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/08/2021
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1