MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for LED LOUPES LIGHT UNIT 15050 manufactured by Integra York, Pa Inc..
[139840521]
The device was returned to the manufacturer for analysis. There was one led loupes light unit returned showing wear. This unit was returned for the reason the charger is getting hot. Tested the battery with the charger over night, the charger was warm but not hot. There was another complaint that the battery does not fit into the battery pack, this is confirmed. This type of damage is consistent with the pins being slightly bent. This complaint is confirmed/damaged worn. No manufacturing, workmanship, or material deficiency has been identified. Device identifier (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139840522]
A customer reported that on (b)(6) 2019, the battery pack and charger of 15050 led loupes light unit was hot. The product was not in contact with the patient. No patient injury or death alleged, and the event did not lead to increase the surgery time. Additional information received on (b)(6) 2019 by the hospital manager stated that the charger they received was not the one pictured on the front of the manual, which was the one they borrowed when testing out the loupes. The charger and battery did not fit well together. The charger got hot as the battery was charging, but probably feels this is due to the two (2) pieces not fitting well together.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00026 |
| MDR Report Key | 8372044 |
| Date Received | 2019-02-26 |
| Date of Report | 2019-01-30 |
| Date of Event | 2019-01-30 |
| Date Mfgr Received | 2019-01-30 |
| Date Added to Maude | 2019-02-26 |
| 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 KIMBERLY SHELLY |
| 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 | LED LOUPES LIGHT UNIT |
| Generic Name | M5 - GENERAL SURGERY |
| Product Code | HJH |
| Date Received | 2019-02-26 |
| Returned To Mfg | 2019-02-13 |
| Catalog Number | 15050 |
| 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 | 2019-02-26 |