MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-11 for CS SOLID HDL SERR W/RULE 67-688 manufactured by Integra York, Pa Inc..
[38700930]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[38700931]
Customer reports this detachable handle as broken. On (b)(6) 2016 customer reports doctor was doing a routine dental exam using the mirror to retract the cheek when the mirror (dexiter usa #5 mirror) came off the universal handle, no harm done. No further information available.
Patient Sequence No: 1, Text Type: D, B5
[40546962]
2//22/16 integra investigation completed. Method : failure analysis, device history evaluation. Results : failure analysis - a mirror handle was returned in used condition, showing wear and an orange tape marking, staining and mirror detached (broken). Upon evaluating the instrument, it is noticed that the mirror has broken off of the handle. Without knowing how the instrument was handled and maintained during use, the cause is undetermined. The instrument appears to be used and old. The complaint report is confirmed; damaged worn. Device history evaluation - dhr review was completed with all history available. Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history. Variance authorization / deviation history: there is no applicable variance authorization / deviation history. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: there is no applicable corrective action preventive action history health hazard evaluation history: none. Conclusion : the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00012 |
| MDR Report Key | 5432201 |
| Date Received | 2016-02-11 |
| Date of Report | 2016-01-13 |
| Date Mfgr Received | 2016-02-22 |
| Device Manufacturer Date | 2016-01-25 |
| Date Added to Maude | 2016-02-11 |
| 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 | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CS SOLID HDL SERR W/RULE |
| Generic Name | M52 - HYGIENE / PERIODONTAL |
| Product Code | EJB |
| Date Received | 2016-02-11 |
| Returned To Mfg | 2016-01-25 |
| Catalog Number | 67-688 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-11 |