MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-05 for PILLING WECK 521310 NA manufactured by Pilling Weck Surgical.
[179717]
Nurse was going to insert pic line, baby was very edematous, with soft tissue "paalinc". Transluminator was used to locate vein. About 6-8 hrs later, blisters developed where tip of light had been placed on skin. It was diagnosed as 2nd degree burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 272727 |
| MDR Report Key | 272727 |
| Date Received | 2000-04-05 |
| Date of Report | 2000-02-25 |
| Date of Event | 2000-02-19 |
| Date Facility Aware | 2000-02-19 |
| Report Date | 2000-02-25 |
| Date Reported to Mfgr | 2000-02-25 |
| Date Added to Maude | 2000-04-11 |
| 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 | PILLING WECK |
| Generic Name | TRANSLUMINATOR |
| Product Code | HBI |
| Date Received | 2000-04-05 |
| Model Number | 521310 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 264031 |
| Manufacturer | PILLING WECK SURGICAL |
| Manufacturer Address | 420 DELAWARE ST. FORT WASHINGTON PA 19034 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-04-05 |