MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-04 for STORZ 26712011 manufactured by *.
[281520]
Pt underwent a laparoscopic myomectomy for a 9 cm pedunculated subserosal fibroid. Pt removed stable and was discharged home the following morning. On postoperative day #4 pt presented with fever, abdominal pain and free air under the diaphragm. At second look a 1. 5 cm circular defect was noted in the anterior sigmoid colon. Third look was required, but pt ultimately survived and was discharged with long-term antibiotic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024599 |
| MDR Report Key | 387174 |
| Date Received | 2002-04-04 |
| Date of Report | 2002-04-04 |
| Date of Event | 2002-02-01 |
| Date Added to Maude | 2002-04-11 |
| 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 |
| 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 | STORZ |
| Generic Name | STEINER MORCELLATOR |
| Product Code | LEC |
| Date Received | 2002-04-04 |
| Model Number | 26712011 |
| Catalog Number | 26712011 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 376189 |
| Manufacturer | * |
| Manufacturer Address | MITTELSTR 8 POSTFACH 230 TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2002-04-04 |