HENRY SCHEIN MULTI-USE DISPENSER FPSCHEIN-175

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-10 for HENRY SCHEIN MULTI-USE DISPENSER FPSCHEIN-175 manufactured by Septodont Inc..

Event Text Entries

[69852236] Evaluation ongoing.
Patient Sequence No: 1, Text Type: N, H10


[69852237] Spontaneous report. (b)(4). Initial information received by dealer on 19-dec-2016 and additional information was received by dealer on 28-dec-2016. Both initial and additional information were sent to septodont on 28-dec-2016. Case 2 of 2. Linked with local reference # (b)(4) (same reporting dental clinic, same device, same reported concern). The 2 cases concern 2 different identified patients: a (b)(6) female patient and a (b)(6) male patient. However, it could not be determined which of these two patients was concerned by the following reported information. On (b)(6) 2016, while dental clinic staff (b)(6) [name reacted for privacy] was placing the resin on the back tooth, the suspect dispenser henry schein multi-use dispenser (lot # not available) snaped and maked a very loud noise. Nobody was hurt or injured but the potential for the car pule to be swallowed was very high. No lot # available. Additional narrative received on 06-feb-2017: a unidose resin capsule was placed in the suspect multiuse dispenser and the dentist was squeezing the resin into the mouth as usual. The suspect device "popped" the very moment the device handle was squeezed. When asked which part of the suspect multiuse dispenser was broken, it is indicated by the complainant it was at "the silver thing at the tip of the gun [suspect multiuse dispenser] when you put the unidose resin", "the hard outer shell broke" and it made such a loud noise it seemed like an actual gun was fired. According to the complainant, the reported breakage had already happened to 3 different multiuse dispensers. Additional information received on 07-feb-2017: it was confirmed by the complainant that the previous two multiuse dispensers "broke in the exact same way.. While dispersing the resin capsule in the mouth.. We are very lucky none of the pieces went down the patient's mouth. " on 08-feb-2017, it was determined by septodont that the reported malfunction failed to perform as intended and that the suspect device is likely to cause or contribute to a serious injury if the malfunction were to recur. On 21-feb-2017, septodont contacted supplier of the a "other number" on the returned device sample was identified as "i6802", which permit septodont to determine device manufacturing date as 09-jul-2014. Call log was received from qa on current investigation status. Causality assessment on 10-mar-2017 by (b)(4) on initial information received on 02-feb-2017, and additional information received on 06-feb-2017, 07-feb-2017, 08-feb-2017 and 21-feb-2017: seriousness: serious (determined by septodont that the reported malfunction failed to perform as intended and that the suspect device is likely to cause or contribute to a serious injury if the malfunction were to recur). Listedness/expectedness: device breakage: unlisted eu; unexpected us/(b)(4). No adverse event: listed eu; expected us/(b)(4). Causality: latency - unknown. Recognized association - no. Analysis - the reporter had 2 similar events of device breakage in 2 identified patients. The device was returned to quality department only for one of them. Breakage of the device could be due to anomaly of the material, however call log received from qa on current investigation status stated that the returned dispenser appeared to be dropped, and that it was heavily used due to buildup on the pin. Therefore, without other information, since no adverse event was reported and considering state of use of the device, the causality between the dispenser and device breakage was assessed as unlikely. The event no adverse event was not assessable. Dechallenge - na. Rechallenge - na. Concluded causality who: unlikely for device breakage, not assessable for no adverse event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001721729-2017-00002
MDR Report Key6395382
Report SourceHEALTH PROFESSIONAL
Date Received2017-03-10
Date of Report2017-03-10
Date of Event2016-11-18
Date Mfgr Received2016-12-28
Device Manufacturer Date2014-07-09
Date Added to Maude2017-03-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMR. LAWRENCE KASS
Manufacturer Street416 SOUTH TAYLOR AVE.
Manufacturer CityLOUISVILLE CO 80027
Manufacturer CountryUS
Manufacturer Postal80027
Manufacturer Phone3036657535
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHENRY SCHEIN MULTI-USE DISPENSER
Generic NameMULTI-USE DISPENSER
Product CodeEIY
Date Received2017-03-10
Returned To Mfg2017-02-16
Catalog NumberFPSCHEIN-175
Lot NumberI6802
OperatorDENTIST
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSEPTODONT INC.
Manufacturer Address418S TAYLOR AVE. LOUISVILLE CO 80027 US 80027


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-03-10

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