MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-17 for LARYNGEAL MIRROR W/HANDLE #4 460105 manufactured by Integra York, Pa Inc..
[57806614]
On 10/05/2016 integra investigation completed. Ten mirrors returned, 4 manufactured in oct/nov 2015 and 6 manufactured in feb 2015. Method: failure analysis, device history evaluation. Results: failure analysis - mirrors returned used with no unusual markings and mirrors falling off of the frames. Upon further investigation, it is noticed that the adhesive that is used to affix the mirrors to the frames is melted and not holding the mirrors on the frames. Device history evaluation - nonconforming product report / nonconforming material report history: none. 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: none. Health hazard evaluation history: none. Conclusion: this is a known issue and appropriate action has been implemented to rectify this manufacturing deficiency.
Patient Sequence No: 1, Text Type: N, H10
[57806615]
Customer initially reports mirrors are not staying glued together. On (b)(6) 2016 customer reports mirrors are falling off in patients mouth, but mainly after sterilization, no harm done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2016-00163 |
| MDR Report Key | 6035279 |
| Date Received | 2016-10-17 |
| Date of Report | 2016-09-19 |
| Date Mfgr Received | 2016-09-19 |
| Date Added to Maude | 2016-10-17 |
| 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 | 0 |
| Brand Name | LARYNGEAL MIRROR W/HANDLE #4 |
| Generic Name | N/A |
| Product Code | KAI |
| Date Received | 2016-10-17 |
| Returned To Mfg | 2016-09-21 |
| Catalog Number | 460105 |
| 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 | 2016-10-17 |