MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-23 for LIGHT CORD * manufactured by Richard Wolf Medical Instruments Corp..
[57150]
There were two incidents of burns, discovered after surgery (3/21/97 and 4/17/97). The first incident occurred when the retractor and light cord were separated and left on the pt inadvertently. In the second incident, the connection between the retractor and the light cord became very hot and caused a half a centimeter burn on the pt. According to the rptr, the connection should not get hot. Both pts were treated with ointment and bandage. No scarring occurred.
Patient Sequence No: 1, Text Type: D, B5
[6331115]
There were two incidents of burns, discovered after surgery. The first incident occurred when the retractor and light cord were separated and left on the pt inadvertently. In the second incident, the connection between the retractor and the light cord became very hot and caused a half a centimeter burn on the pt. According to the rptr, connection showed hot get hot. Both pts were treated with ointment and band-aid. No scarring occurred.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | MW1011182 |
| MDR Report Key | 86004 |
| Date Received | 1997-04-23 |
| Date of Report | 1997-04-23 |
| Date of Event | 1997-03-21 |
| Date Added to Maude | 1997-04-25 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT CORD |
| Generic Name | LIGHT CORD |
| Product Code | FCR |
| Date Received | 1997-04-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 85205 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | 353 CORPORATE WOODS PKWY VERNON HILLS IL 60061 US |
| Baseline Brand Name | AUTO-IRIS FIBER LIGHT PROJECTOR |
| Baseline Generic Name | FIBER LIGHT PROJECTOR |
| Baseline Model No | 5119.00 |
| Baseline Catalog No | 5119.00 |
| Baseline ID | 867 |
| Baseline Device Family | FIBER LIGHT PROJECTOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-23 |
| 2 | 0 | 1. Other | 1997-04-23 |