MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-31 for MIRROR - DBL SIDED, SZ 4 67722 manufactured by Integra York, Pa Inc..
[84272614]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[84272615]
Customer initially reports mirrors came off. On (b)(6) 2017 doctor reports no harm done.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2523190-2017-00086 |
MDR Report Key | 6835667 |
Report Source | USER FACILITY |
Date Received | 2017-08-31 |
Date of Report | 2017-08-08 |
Date Mfgr Received | 2017-09-05 |
Date Added to Maude | 2017-08-31 |
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 4 |
Generic Name | M52 - HYGIENE / PERIODONTAL |
Product Code | EAX |
Date Received | 2017-08-31 |
Catalog Number | 67722 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
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 | 2017-08-31 |