MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-06 for HEADLIGHT VAR 10-75MM SPOT W/8' CABLE 528341P manufactured by Teleflex Medical.
[153648705]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[153648706]
It was reported that the light source and headlamp purchased back in (b)(6) 2018. The headlamp melted during the procedure. There was no reported patient or staff injury.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3011137372-2019-00239 |
MDR Report Key | 8866532 |
Date Received | 2019-08-06 |
Date of Report | 2019-07-17 |
Date of Event | 2019-07-17 |
Date Mfgr Received | 2019-09-13 |
Date Added to Maude | 2019-08-06 |
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 | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | JASMINE BROWN |
Manufacturer Street | 3015 CARRINGTON MILL BLVD |
Manufacturer City | MORRISVILLE NC 27560 |
Manufacturer Country | US |
Manufacturer Postal | 27560 |
Manufacturer Phone | 9193614124 |
Manufacturer G1 | TELEFLEX MEDICAL |
Manufacturer Street | 3015 CARRINGTON MILL BLVD |
Manufacturer City | MORRISVILLE NC 27560 |
Manufacturer Country | US |
Manufacturer Postal Code | 27560 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | HEADLIGHT VAR 10-75MM SPOT W/8' CABLE |
Product Code | FQP |
Date Received | 2019-08-06 |
Catalog Number | 528341P |
Lot Number | UNKNOWN |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TELEFLEX MEDICAL |
Manufacturer Address | RESEARCH TRIANGLE PARK NC |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-08-06 |