MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-05 for H/S CATHETER SET 61-3007 manufactured by Ackrad Laboratories, Inc..
[87400]
Investigation of event strongly indicates that the h/s catheter in question was in no way contributory to the adverse reaction: 1. There were no symptoms until the contrast material was introduced and the catheter removed. 2. Allergic or reactions to osmotic effects are well known in radiology; there have been no previous reports of such a reaction with this product in more than 500,000 procedures.
Patient Sequence No: 1, Text Type: D, B5
[20770823]
Investigation of event strongly indicates that the h/s catheter in question was in no way contributory to the adverse reaction: 1. There were no symptoms until the contrast material was introduced and the catheter removed. 2. Allergic or reactions to osmotic effects are well known in radiology; there have been no previous reports of such a reaction with this product in more than 500,000 procedures. 3. In a separate telephone conversation with the reporter, it was disclosed that the pt was extremely tense before the procedure even began.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011400 |
| MDR Report Key | 96210 |
| Date Received | 1997-06-05 |
| Date of Report | 1997-06-05 |
| Date of Event | 1997-05-20 |
| Date Added to Maude | 1997-06-09 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | H/S CATHETER SET |
| Generic Name | H/S CATHETER SET FOR HYSTEROSALPINGOGRAPHY |
| Product Code | MOV |
| Date Received | 1997-06-05 |
| Model Number | NA |
| Catalog Number | 61-3007 |
| Lot Number | 6076 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 94991 |
| Manufacturer | ACKRAD LABORATORIES, INC. |
| Manufacturer Address | 70 JACKSON DR. CRANFORD NJ 07016 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-05 |