MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-12 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Integra York, Pa Inc..
[52720779]
On 7/29/16 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - the returned mirror shows scratched reflective surface and detached from frames. While inspecting the mirror it is also noticed that the mirror is detached and have fallen out of frame. Without knowing what temperatures were used when in autoclave and how the mirror was handled during wiping; the cause is undetermined. This type of damage can happen when heat penetrates the reflective surface during autoclaving. The complaint report is confirmed. Device history evaluation - dhr review: nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: issued for the mirror glass becoming separated from the mirror frame. Issued for double side mirror glass separating form the frame. Health hazard evaluation history: issued for the following reasons: mirror detaching from the frame. Conclusion: the root cause has been identified as a workmanship or material deficiency. Appropriate action has been implemented to rectify this manufacturing deficiency.
Patient Sequence No: 1, Text Type: N, H10
[52720780]
Customer initially reports mirrors are coming off of the surface, coming unglued. Fell off in patients mouths. On (b)(6) 2016 customer reports no harm done. This is #3 of 3 related complaints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2016-00125 |
| MDR Report Key | 5873647 |
| Report Source | USER FACILITY |
| Date Received | 2016-08-12 |
| Date of Report | 2016-07-20 |
| Date Mfgr Received | 2016-07-20 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2016-08-12 |
| 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 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 | MIRROR - DBL SIDED, SZ 5 |
| Generic Name | M52 - HYGIENE / PERIODONTAL |
| Product Code | EAX |
| Date Received | 2016-08-12 |
| Returned To Mfg | 2016-07-21 |
| Catalog Number | 67723 |
| Lot Number | M0119 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-08-12 |