MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-08 for ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER manufactured by Cook Inc.
[92741226]
Additional information: common device name is "gbo. " due to a technical issue, this information could not be saved in the proper field, so it is being recorded here. D4- rpn- ult12. 0-38-25-p-5s-cldm-tong-050399. This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[92741227]
It was reported that prior to patient contact, leakage occurred from the catheter's hub area, a new product was used. There was no of injuries.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1820334-2017-03845 |
MDR Report Key | 7008991 |
Date Received | 2017-11-08 |
Date of Report | 2017-11-07 |
Date of Event | 2014-10-20 |
Date Mfgr Received | 2017-11-07 |
Device Manufacturer Date | 2013-09-01 |
Date Added to Maude | 2017-11-08 |
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 | 8128294891 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER |
Product Code | EYI |
Date Received | 2017-11-08 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | R |
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 | 2017-11-08 |