MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-10 for HENRY SCHEIN MULTI-USE DISPENSER FPSCHEIN-175 manufactured by Septodont Inc..
[70058518]
Evaluation ongoing.
Patient Sequence No: 1, Text Type: N, H10
[70058519]
(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 (b)(4) on 28-dec-2016. Case 1 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) was placing the resin on the back tooth. The suspect dispenser henry schein multi-use dispenser (lot # not available) snaps and makes 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 luck none of the pieces went down the patient at mouth". On 08-feb-2017, it was determined by (b)(4) 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, (b)(4) 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 al 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 (b)(4) 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/ca. No adverse event: listed eu; expected us/ca. 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
| Report Number | 0001721729-2017-00001 |
| MDR Report Key | 6395374 |
| Date Received | 2017-03-10 |
| Date of Report | 2017-03-10 |
| Date of Event | 2016-11-18 |
| Date Mfgr Received | 2016-12-28 |
| Device Manufacturer Date | 2014-07-09 |
| Date Added to Maude | 2017-03-10 |
| 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 Contact | MR. LAWRENCE KASS |
| Manufacturer Street | 416 SOUTH TAYLOR AVE. |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal | 80027 |
| Manufacturer Phone | 3036657535 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HENRY SCHEIN MULTI-USE DISPENSER |
| Generic Name | MULTI-USE DISPENSER |
| Product Code | EIY |
| Date Received | 2017-03-10 |
| Returned To Mfg | 2017-02-16 |
| Catalog Number | FPSCHEIN-175 |
| Lot Number | I6802 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEPTODONT INC. |
| Manufacturer Address | 418S TAYLOR AVE. LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-10 |