MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-08 for ZUM 4.5 * manufactured by Zsi Gynocological Products.
[99262]
After procedure, physician noted uterine perforation - it is suspected that a humi manipulator may have been the cause. Pt admitted for observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 175823 |
| MDR Report Key | 175823 |
| Date Received | 1998-07-08 |
| Date of Report | 1998-06-26 |
| Date of Event | 1998-06-12 |
| Date Facility Aware | 1998-06-12 |
| Report Date | 1998-07-01 |
| Date Reported to FDA | 1998-07-01 |
| Date Reported to Mfgr | 1998-07-01 |
| Date Added to Maude | 1998-07-09 |
| 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 | 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 | ZUM 4.5 |
| Generic Name | HUME MANIPULATOR |
| Product Code | HDC |
| Date Received | 1998-07-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 065123 |
| ID Number | DISPOSABLE |
| Device Expiration Date | 2003-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 170961 |
| Manufacturer | ZSI GYNOCOLOGICAL PRODUCTS |
| Manufacturer Address | 21540 PRARIE ST SUITE B CHATSWORTH CA 91311 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 1998-07-08 |