MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-17 for GM11011160 UNIVERSAL STUMP APPLICATOR SET manufactured by Varian Medical Systems Haan Gmbh.
[145416197]
Female brachy therapy patient was undergoing brachy procedure. The patient was scheduled for fraction 1 of vaginal cylinder treatment.? The applicator was placed and ct scan was completed. Patient experienced severe discomfort and the applicator was removed. The patient was then taken to the emergency room.? The vaginal wall had ruptured and small bowel was protruding into the vagina. The patient was taken into surgery. After the incident occurred, the site reviewed the ct images and discovered the rigid guide tube had pushed out of the cylinder dome. The site physicians report that this caused the injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612638-2019-00001 |
| MDR Report Key | 8620141 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-17 |
| Date of Report | 2019-08-20 |
| Date of Event | 2019-05-07 |
| Date Mfgr Received | 2019-05-15 |
| Device Manufacturer Date | 2018-06-15 |
| Date Added to Maude | 2019-05-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. K. SEMONE |
| Manufacturer Street | 911 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 943041028 |
| Manufacturer Country | US |
| Manufacturer Postal | 943041028 |
| Manufacturer Phone | 6504246833 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GM11011160 UNIVERSAL STUMP APPLICATOR SET |
| Generic Name | GM11011160 UNIVERSAL STUMP APPLICATOR SET |
| Product Code | JAQ |
| Date Received | 2019-05-17 |
| Model Number | GM11011160 |
| Catalog Number | GM11011160 |
| Lot Number | T24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS HAAN GMBH |
| Manufacturer Address | BERGISCHE STRASSE 16 HAAN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-17 |