MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-18 for CONTURA MLB CATHETER WITH TRICONCAVE B01245 NA manufactured by Hologic, Inc..
[89630565]
Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known. The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known. If additional relevant information is received, a supplemental medwatch will be filed. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant. Internal reference complaint#:(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89630566]
Limited information was reported by a physician (b)(6) 2017: a physician performed a contura procedure for brachytherapy. The physician had a question regarding an "apparent allergic reaction. She has been performing balloon implants since 2003, and she has never seen an allergic reaction before". We have been unable to obtain additional information surrounding this event.
Patient Sequence No: 1, Text Type: D, B5
[109932017]
This event was reported inadvertently. This product is latex free and there are no known allergic-type materials used within the device. It is unknown what gloves were used. There was no malfunction of our device and no serious injury. This event has been reassessed to not reportable. If additional information is received at a later date a supplement will be file.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2017-00255 |
| MDR Report Key | 6958871 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-18 |
| Date of Report | 2017-09-18 |
| Date Mfgr Received | 2017-10-18 |
| Date Added to Maude | 2017-10-18 |
| 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 | MS. SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTURA MLB CATHETER WITH TRICONCAVE |
| Generic Name | CONTURA MLB SOURCE APPLICATION FOR BRACHYTHERAPY |
| Product Code | JAQ |
| Date Received | 2017-10-18 |
| Model Number | B01245 |
| Catalog Number | NA |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-18 |