MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-04 for HYPAQU -60% CONTRAST MEDIUM N/A H-580 manufactured by Winthrop Pharmaceuticals.
[4840]
Patient was scheduled for outpatient i. V. P procedure. Received 20cc's of contrast medium to which he immediately reacted. There were administered during the code. The patient developed cardiac arrrythmia and needed to be intubated. He was admitted to icu where he remained for 24 hours. He was then extubated and moved to a general floor. He was not defibrillated during the. Patient was discharged on 10/21/93 with all effects of the reaction resolved. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7677 |
| MDR Report Key | 7677 |
| Date Received | 1994-02-04 |
| Date of Report | 1993-11-30 |
| Date of Event | 1993-10-13 |
| Date Facility Aware | 1993-10-13 |
| Report Date | 1993-11-30 |
| Date Reported to Mfgr | 1993-11-29 |
| Date Added to Maude | 1994-05-09 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPAQU -60% CONTRAST MEDIUM |
| Generic Name | N/A |
| Product Code | KTA |
| Date Received | 1994-02-04 |
| Model Number | N/A |
| Catalog Number | H-580 |
| Lot Number | M1205N OR M050KJ |
| ID Number | N/A |
| Device Expiration Date | 1995-11-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 7356 |
| Manufacturer | WINTHROP PHARMACEUTICALS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-02-04 |