MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2016-11-15 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Integra York, Pa Inc..
[60075343]
On 11/10/2016 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis - there were 13 double-sided mirrors, 12 manufactured in july 2016 and 1 manufactured in dec. 2015. The returned mirrors were showing a crack in one mirror, one has completely fallen off of the frame, some of them are coming apart from the frames but none are showing any unusual markings. Upon further investigation it is noticed that some of the mirrors seem to be intact, and one is lifting off of the frame. Appropriate action has been implemented to rectify this manufacturing deficiency. Device history evaluation - 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 double side mirror glass separating form the frame. Health hazard evaluation history: issued for mirror detaching from the frame. Conclusion: the complaint report is confirmed; the root cause has been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[60075344]
Customer initially reports fell out of patients mouth. On (b)(6) 2016 doctor reports mirror fell out of frame during teeth cleaning, easily removed no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2016-00184 |
| MDR Report Key | 6103221 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2016-11-15 |
| Date of Report | 2016-10-20 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2016-10-20 |
| Date Added to Maude | 2016-11-15 |
| 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 | 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 | 2016-11-15 |
| Returned To Mfg | 2016-11-10 |
| Catalog Number | 67723 |
| Lot Number | UNKNOWN |
| 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 | 2016-11-15 |