MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-12-07 for HU-FRIEDY SUB-0 VISION CURETTE #6 SGCSUB-06 manufactured by Hu-friedy Mfg. Co., Llc.
[2367453]
A periodontist was performing scaling and root planning on pt's supper left side between 12 & 13 when the curette broke off and became embedded in the pt's tissue. The doctor confirmed with an x-ray that the tip was embedded and then proceeded to perform a periodontal flap surgery for removal the tip and debridement of the area.
Patient Sequence No: 1, Text Type: D, B5
[9563363]
Thickness at the heel of the unbroken working end measures 0. 0185" and the thickness in the middle of the blade measures 0. 0215". Both measurements are within the specification of 0. 020" +/- 0. 002. " based on visual/dimensional analysis, the reason for the breakage of the instrument cannot be determined. Add'l functional testing will be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2011-00004 |
| MDR Report Key | 2379116 |
| Report Source | 06 |
| Date Received | 2011-12-07 |
| Date of Report | 2011-12-05 |
| Date of Event | 2011-10-17 |
| Date Mfgr Received | 2011-11-21 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-07-19 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7739753975 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY SUB-0 VISION CURETTE #6 |
| Generic Name | SGCSUB - 06 |
| Product Code | EKT |
| Date Received | 2011-12-07 |
| Returned To Mfg | 2011-11-21 |
| Model Number | SGCSUB-06 |
| Catalog Number | SGCSUB-06 |
| Lot Number | 0711 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Address | CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-07 |