MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for UROLIFT IPN055826 UL400-4 manufactured by Teleflex Incorporated.
[178573472]
Hair found in sterile package prior to opening the device. Not used on a patient or ever opened the device package. Manufacturer response for urology device, urolift system (per site reporter) called the rep to inform him of the situation. He will replace the device with one that does not have a hair in it.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9693211 |
MDR Report Key | 9693211 |
Date Received | 2020-02-11 |
Date of Report | 2020-02-07 |
Date of Event | 2020-02-07 |
Report Date | 2020-02-07 |
Date Reported to FDA | 2020-02-07 |
Date Reported to Mfgr | 2020-02-11 |
Date Added to Maude | 2020-02-11 |
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 | UROLIFT |
Generic Name | IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM |
Product Code | PEW |
Date Received | 2020-02-11 |
Model Number | IPN055826 |
Catalog Number | UL400-4 |
Lot Number | P42721 |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TELEFLEX INCORPORATED |
Manufacturer Address | PO BOX 12600 DURHAM NC 27709 US 27709 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-11 |