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 2020-01-06 for ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER N/A ULT8.5-38-25-P-6S-CLM-RH manufactured by Cook Inc.
[185683550]
Initial reporter? Occupation: unknown. Pma/510(k) #: exempt. (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
[185683551]
It was reported that an (b)(6) year old male patient required the placement of an ultrathane mac-loc locking loop multipurpose drainage catheter during a procedure to drain a liver abscess on (b)(6) 2019. The operator stated he placed drainage catheters on both sides of the hepatic duct. At an unspecified time after the procedure, the right drainage catheter was noted to be leaking at the "hub near the mac-loc. " on (b)(6) 2019, the operator replaced the leaking catheter with another, new device. No other adverse effects were reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00056 |
| MDR Report Key | 9553152 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2020-01-06 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-07-05 |
| Date Added to Maude | 2020-01-06 |
| 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 | MRS. JENNIFER CANADA |
| 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 MULTIPURPOSE DRAINAGE CATHETER |
| Generic Name | GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY |
| Product Code | GBO |
| Date Received | 2020-01-06 |
| Model Number | N/A |
| Catalog Number | ULT8.5-38-25-P-6S-CLM-RH |
| Lot Number | 9858575 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2020-01-06 |