MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-02 for MEDCOMP UNK manufactured by *.
[22185760]
Pt dialyzed for 2 hrs and 45 mins when she developed stomach cramps. Pt rinsed back and went to restroom. Vaginal bleeding noted. Pt had hysterectomy 7 years ago. Hct dropped from 33 to 25%. Pt sent to hosp. Hemolysis identified. She was transfused.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 60318 |
| MDR Report Key | 60318 |
| Date Received | 1996-07-02 |
| Date of Report | 1996-05-01 |
| Date of Event | 1996-04-19 |
| Date Facility Aware | 1996-04-22 |
| Report Date | 1996-05-01 |
| Date Reported to Mfgr | 1996-05-01 |
| Date Added to Maude | 1997-01-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | MEDCOMP |
| Generic Name | PERMACATH |
| Product Code | FIQ |
| Date Received | 1996-07-02 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | OTHER |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 60724 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1996-07-02 |