MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2018-08-07 for URODYNAMICS CATHETER 020207 manufactured by Cook Inc.
[116272918]
Occupation: non-healthcare professional. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[116272919]
It was reported, prior to opening the sterile package of the urodynamics catheter, a "hair like" material was observed inside the package. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1820334-2018-02353 |
MDR Report Key | 7758010 |
Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
Date Received | 2018-08-07 |
Date of Report | 2018-09-21 |
Date of Event | 2018-07-30 |
Date Mfgr Received | 2018-09-20 |
Device Manufacturer Date | 2018-01-16 |
Date Added to Maude | 2018-08-07 |
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. LARRY POOL |
Manufacturer Street | 750 DANIELS WAY |
Manufacturer City | BLOOMINGTON IN 47404 |
Manufacturer Country | US |
Manufacturer Postal | 47404 |
Manufacturer Phone | 8123392235 |
Manufacturer G1 | COOK INC |
Manufacturer Street | 750 DANIELS WAY |
Manufacturer City | BLOOMINGTON IN 47404 |
Manufacturer Country | US |
Manufacturer Postal Code | 47404 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | URODYNAMICS CATHETER |
Generic Name | FAP CYTOMETRIC GAS (CARBON DIOXIDE |
Product Code | FAP |
Date Received | 2018-08-07 |
Returned To Mfg | 2018-09-04 |
Catalog Number | 020207 |
Lot Number | 8513243 |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | COOK INC |
Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-08-07 |