MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-19 for MARYLAND * T.0050.20 manufactured by Gimmi Gmbh.
[635981]
Patient with dysfunctional uterine bleeding. She underwent total laparascopic hysterectomy and bso and cystoscopy with no apparent perioperative complications. She was discharged home on post operative day (pod) #2. On pod #4 she presented with nausea and vomiting and was admitted. She developed a fever. Ct scan showed abdominal abscess. Three days later she underwent exploratory laparatomy, repair of colonic perforation and end colostomy. She was discharged home nine days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 845245 |
| MDR Report Key | 845245 |
| Date Received | 2007-04-19 |
| Date of Report | 2007-04-19 |
| Date of Event | 2007-03-12 |
| Report Date | 2007-04-19 |
| Date Reported to FDA | 2007-04-19 |
| Date Added to Maude | 2007-05-09 |
| 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 |
| 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 | MARYLAND |
| Generic Name | ESU, BIPOLAR FORCEP |
| Product Code | HCZ |
| Date Received | 2007-04-19 |
| Model Number | * |
| Catalog Number | T.0050.20 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 832343 |
| Manufacturer | GIMMI GMBH |
| Manufacturer Address | CARL-ZEISS-STRASSE 6 TUTTLINGEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-19 |