MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-30 for THE INFINITY TRANSILLUMINATOR IT-101 UNK manufactured by Fiberoptic Medical Products, Inc.
[16404571]
Infant suffered two, second-degree burns following transillumination to facilitate puncture of the left ulnar wrist artery. The infrared blocking filter was found to be dislodged, resulting in increased light intensity and increased temperature to the skin surface of the back of the wrists. The injury consisted of two, second-degree burns of 1/2cm each to the anterior side of the wrists. Each second-degree burn resulted in a raised, fluid-filled vesicle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 358788 |
| MDR Report Key | 358788 |
| Date Received | 2001-10-30 |
| Date of Report | 2001-10-30 |
| Date of Event | 2001-10-15 |
| Date Facility Aware | 2001-10-19 |
| Report Date | 2001-10-30 |
| Date Reported to FDA | 2001-10-30 |
| Date Reported to Mfgr | 2001-10-30 |
| Date Added to Maude | 2001-11-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE INFINITY TRANSILLUMINATOR |
| Generic Name | PORTABLE HIGH-POWERED FIBEROPTIC EXAMINATION LIGHT |
| Product Code | MQW |
| Date Received | 2001-10-30 |
| Model Number | IT-101 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | IMMC #32175 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9.5 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 347971 |
| Manufacturer | FIBEROPTIC MEDICAL PRODUCTS, INC |
| Manufacturer Address | 5100 TILGHMAN ST SUITE 300 ALLENTOWN PA 18104 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2001-10-30 |