METAPASTE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for METAPASTE manufactured by Meta Dental Corp..

Event Text Entries

[131621085] On (b)(6) 2018, endodontist overfilled root canal of tooth number 30 resulting in anesthesia and dysesthesia of my right inferior alveolar nerve. On (b)(6) 2018, oral surgeon removed metapaste overfill and neuroma. Grafting done for inferior alveolar nerve repair with very guarded prognosis. Anesthesia is likely permanent. Neuropathic pain improved post nerve repair surgery. Anesthesia and dysesthesia secondary to tooth number 30 root canal overfilled of metapaste into the inferior alveolar nerve. Date the person first started using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018; did the problem stop after the person reduced the dose or stopped taking or using the product? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5082543
• MDR Report Key: 8194409
• Date Received: 2018-12-21
• Date of Report: 2018-12-13
• Date of Event: 2018-10-24
• Date Added to Maude: 2018-12-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: METAPASTE
• Generic Name: RESIN, ROOT CANAL FILLING
• Product Code: KIF
• Date Received: 2018-12-21
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: META DENTAL CORP.

Device Sequence Number: 1

• Brand Name: METAPASTE
• Generic Name: RESIN, ROOT CANAL FILLING
• Product Code: KIF
• Date Received: 2018-12-21
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: META DENTAL CO.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2018-12-21