MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2014-02-05 for SHOFU BROWNIE CUPS 0411 manufactured by Shofu Dental Corp..
[18806963]
Initial reporter contacted shofu dental corp on (b)(6) 2012 with info regarding an injury to a dental patient while using one of our abrasives. The injury occurred on (b)(6) 2012. Initial reporter stated that while using one of shofu's abrasives at slow speed with water on tooth number 30, the silicone portion of the abrasive broke apart from the shank, lacerating the patient's mouth. Initial reporter observed that the stainless steel shank was bent and recalled hearing a loud popping sound just before the abrasive came apart. The site of the injury required the use of a topical and gauze to stop bleeding with the use of antibiotics as a follow up. Pt returned on (b)(6) 2012, complaining of pain at the site of the injury. Pt was then referred to an oral surgeon for removal of a piece of the broken abrasive from the site of the injury. Initial reporter refused to send broken (suspect) abrasive to shofu, sending a picture and the container from which the broken abrasive was taken along with two add'l unused abrasives that allegedly came from the same container. Pt fully recovered and the picture and one of the two extra unused abrasives were sent to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
[19210623]
Without being able to evaluate the suspect device, manufacturer can only assume that the user exceeded performance specifications of max 30,000 speed which created large centrifugal force thus bending the shank and breaking the abrasive. In general, high speed rotation typically causes this event with dental abrasives.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916735-2014-00001 |
| MDR Report Key | 3628678 |
| Report Source | 01,05,08 |
| Date Received | 2014-02-05 |
| Date of Report | 2012-12-18 |
| Date of Event | 2012-12-13 |
| Date Facility Aware | 2012-12-18 |
| Report Date | 2014-02-03 |
| Date Reported to FDA | 2014-02-03 |
| Date Reported to Mfgr | 2014-02-03 |
| Date Mfgr Received | 2012-12-18 |
| Date Added to Maude | 2014-02-18 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 11 KAMITAKAMATSU-CHO, FUKUINE |
| Manufacturer City | HIGASHIYAMA-KU 605-0983 |
| Manufacturer Country | JA |
| Manufacturer Postal | 605-0983 |
| Manufacturer Phone | 8175561041 |
| Manufacturer G1 | SHOFU DENTAL INC |
| Manufacturer Street | 11 KAMITAKAMATSU-CHO, FUKUINE |
| Manufacturer City | HIGASHIYAMA-KU |
| Manufacturer Country | JA |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOFU BROWNIE CUPS |
| Generic Name | POINT, ABRASIVE |
| Product Code | EHL |
| Date Received | 2014-02-05 |
| Model Number | 0411 |
| Catalog Number | 0411 |
| Lot Number | 1005254 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHOFU DENTAL CORP. |
| Manufacturer Address | 11 KAMITAKAMATSU-CHO FUKUINE HIGASHIYAMA-KU JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-05 |