MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-14 for BATTERY CHARGER, SINGLE BAY 90523 manufactured by Integra York, Pa Inc..
Report Number | 2523190-2019-00082 |
MDR Report Key | 8699811 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-06-14 |
Date of Report | 2019-05-27 |
Date Mfgr Received | 2019-08-26 |
Date Added to Maude | 2019-06-14 |
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 | MS. KIMBERLY SHELLY |
Manufacturer Street | 311 ENTERPRISE DRIVE |
Manufacturer City | PLAINSBORO NJ 08536 |
Manufacturer Country | US |
Manufacturer Postal | 08536 |
Manufacturer Phone | 6099362319 |
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 | BATTERY CHARGER, SINGLE BAY |
Generic Name | LIGHTING |
Product Code | FSR |
Date Received | 2019-06-14 |
Catalog Number | 90523 |
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 | 2019-06-14 |