MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2017-11-09 for BARD? BRACHYSOURCE? I-125 IMPLANT SEED 1251QCL manufactured by Bard Brachytherapy, Inc. -1424526.
[91746643]
The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use states the following: "i-125 has a 59. 6 day half life1. Decay corrections must be made to properly calculate the activity of the brachysource? Seed implants from the labeled reference date to the day they are implanted. To correct for the physical decay of iodine-125, the decay factors at selected days before and after the assay date are shown in the table below:" (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[91746646]
It was reported that the seed activity on the local assay was not in the normal agreement with each other. (the facility verified this from their seed activity measurements and paperwork) due to the concern over the correct activity, the physician chose to cancel the (b)(6) 2017 implant and reschedule with a new set of seeds for implant on (b)(6) 2017. This is the extent of the information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-05790 |
| MDR Report Key | 7015186 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-09 |
| Date Mfgr Received | 2017-10-16 |
| Date Added to Maude | 2017-11-09 |
| 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 |
| Reporter Occupation | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | BARD BRACHYTHERAPY, INC. -1424526 |
| Manufacturer Street | 295 EAST LIES ROAD |
| Manufacturer City | CAROL STREAM IL 60188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? BRACHYSOURCE? I-125 IMPLANT SEED |
| Generic Name | I125 QUICKLINK CARTRIDGE SINGLE |
| Product Code | KXK |
| Date Received | 2017-11-09 |
| Model Number | 1251QCL |
| Catalog Number | 1251QCL |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD BRACHYTHERAPY, INC. -1424526 |
| Manufacturer Address | 295 EAST LIES ROAD CAROL STREAM IL 60188 US 60188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-09 |