MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-29 for ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER N/A ULT8.5-38-40-P-32S-CLB-RH manufactured by Cook Inc.
[144153985]
Occupation: unknown. Pma/510(k) #: preamendment. 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
[144153986]
It was reported a ultrathane mac-loc locking loop biliary drainage catheter was used in an unknown patient for a drainage procedure. As reported,? It was impossible to remove the blue part of the drain (stiffening cannula). They used a new drain. " as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00999 |
| MDR Report Key | 8562291 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-29 |
| Date of Report | 2019-06-27 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-06-26 |
| Device Manufacturer Date | 2019-02-11 |
| Date Added to Maude | 2019-04-29 |
| 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 | ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER |
| Generic Name | GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY |
| Product Code | GCA |
| Date Received | 2019-04-29 |
| Returned To Mfg | 2019-06-18 |
| Model Number | N/A |
| Catalog Number | ULT8.5-38-40-P-32S-CLB-RH |
| Lot Number | 9510476 |
| 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 | 2019-04-29 |