MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2018-12-27 for MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET C-OECS-400-MIXTER manufactured by Cook Inc.
[131589062]
Pma/510(k) #: exempt. 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
[131589063]
It was reported foreign matter, piece of hair, was found in the sealed sterile package of a mixter endoscopic cholangiography set during incoming inspection. The device did not make patient contact.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1820334-2018-03707 |
MDR Report Key | 8200089 |
Report Source | DISTRIBUTOR,FOREIGN,OTHER |
Date Received | 2018-12-27 |
Date of Report | 2019-03-01 |
Date of Event | 2018-11-06 |
Date Mfgr Received | 2019-02-06 |
Device Manufacturer Date | 2018-02-27 |
Date Added to Maude | 2018-12-27 |
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 | MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET |
Generic Name | GBZ CATHETER, CHOLANGIOGRAPHY |
Product Code | GBZ |
Date Received | 2018-12-27 |
Returned To Mfg | 2018-12-05 |
Model Number | NA |
Catalog Number | C-OECS-400-MIXTER |
Lot Number | 8629196 |
Operator | HEALTH PROFESSIONAL |
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 | 2018-12-27 |