SEPTOJECT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-05-01 for SEPTOJECT manufactured by Septodont.

Event Text Entries

[143682802] Spontaneous report, from (b)(6). (b)(4). Initial information received on 01-apr-2019 from the dentist during quality investigation. The dentist reported that she used dental short needle septoject (batch f06214ab) on several patients (unspecified gender) with no specified medical history. On unspecified date, before performing intraseptal and intraligamentary injections on patients, the dentist bended the needles. During injections, the needles broken in patients' mouth. The fragments could be recovered without any adverse effect on the patient by the practitioner. The patients recovered. The company coded "wrong technique in device usage process" since the dentist did not respect the instructions of use mentioned in the ifu. Additional information will follow. Causality assessment on 05-april-2019 on initial information received on 01-apr-2019: seriousness: serious (required intervention to prevent permanent impairment/damage (devices)). Expectedness: foreign body in mouth: unexpected (b)(6)/us; needle issue: unexpected (b)(6)/us; wrong technique in device usage process: unexpected (b)(6)/us; no adverse reaction: expected (b)(6)/us. Causality: latency - compatible; recognized association -no; analysis -the reported incident of device breakage in patient mouth seems to be more likely due to the inappropriate device use since it was bended prior to the use. Therefore the causality is assessed as unlikely. Dechallenge -na. Rechallenge - na. Concluded causality who: unlikely.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9610964-2019-00002
• MDR Report Key: 8568755
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-05-01
• Date of Report: 2019-06-21
• Date Mfgr Received: 2019-05-22
• Date Added to Maude: 2019-05-01
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 58, RUE DU PONT DE CRETEIL
• Manufacturer City: SAINT MAUR DES FOSSESS, 94107
• Manufacturer Country: FR
• Manufacturer Postal: 94107
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SEPTOJECT
• Generic Name: SEPTOJECT
• Product Code: DZM
• Date Received: 2019-05-01
• Lot Number: F06214AB
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SEPTODONT
• Manufacturer Address: 58, RUE DU PONT DE CRETEIL SAINT MAUR, CEDEX VAL-DE-MARNE, 94107 FR 94107

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-05-01