MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-14 for SMIT SLEEVE 189565-00 manufactured by Elekta Inc. (nucletron B.v.).
[120252441]
Surgeon brought implant, smit sleeve t-mr brachytherapy, to operating room to insert into patients vagina. The nurse checked package along with expiration date. Expiration date read, 2015-12. Nurse stated to surgeon that the item brought was expired. Surgeon contacted another physician who supplied the smit sleeve, via phone call. Physician contacted insisted that this type of implant does not expire. Surgeon opened package and continued to use the item.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7876233 |
| MDR Report Key | 7876233 |
| Date Received | 2018-09-14 |
| Date of Report | 2018-09-12 |
| Date of Event | 2017-10-03 |
| Report Date | 2018-09-12 |
| Date Reported to FDA | 2018-09-12 |
| Date Reported to Mfgr | 2018-09-14 |
| Date Added to Maude | 2018-09-14 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMIT SLEEVE |
| Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED |
| Product Code | JAQ |
| Date Received | 2018-09-14 |
| Model Number | 189565-00 |
| Lot Number | 104479 |
| Device Availability | N |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INC. (NUCLETRON B.V.) |
| Manufacturer Address | 400 PERIMETER CENTER TER NE SUITE 50 ATLANTA GA 30346 US 30346 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-14 |