MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-08 for KODAK INSIGHT VHC CHEST FILM * manufactured by Kodak Health Imaging System, Inc..
[26246]
Pt admitted through the emergency dept with chest pain. Cxr revealed free air below the left hemidiaphragm, repeat cxr revealed the same. Diagnosis in ed perforated abdominal viscous, probable perforated ulcer. Taken to surgery for emergency laparotomy, upon exploration no perforation was located anywhere within the stomach or gi tract. Gangrenous gallbladder was found and removed. Upon review by the radiologist felt free air noted on film was actually artifact on the film. Concern is potential existed for unneccessary surgery. Co was contacted on tuesday 1/2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 35676 |
| MDR Report Key | 35676 |
| Date Received | 1996-07-08 |
| Date of Report | 1996-01-24 |
| Date of Event | 1995-12-30 |
| Date Facility Aware | 1995-12-31 |
| Report Date | 1996-01-24 |
| Date Added to Maude | 1996-08-22 |
| 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 | KODAK INSIGHT VHC CHEST FILM |
| Generic Name | RADIOLOGICAL CXR FILM |
| Product Code | IWZ |
| Date Received | 1996-07-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 37104 |
| Manufacturer | KODAK HEALTH IMAGING SYSTEM, INC. |
| Manufacturer Address | 343 STATE ST ROCHESTER NY * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-07-08 |