MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-02-28 for SILICONE MALECOT CATHETER 083808 manufactured by Cook Urological Inc.
[20916719]
On two separate occasions in the last couple of weeks, the pt(s) came back to the physician for the drain(s) to be removed. While he was removing the drain (s), it broke off. In both cases, the pts had to return the next day and have the device(s) surgically removed. Same results with both occurrences. Pts are doing okay.
Patient Sequence No: 1, Text Type: D, B5
[21150831]
One used malecot catheter tip was rec'd noting the remainder of the catheter was not rec'd. A second catheter was also used on the second pt with the same occurrence, however, the device was not returned. The malecot tip appears to have been separated from the catheter shaft at the bond. The point of separation has a concave appearance indicating the device had once been bonded to the catheter. The device has been returned to the supplier for a complete eval of the area of separation and upon receipt of the results the info will be forwarded. Info rec'd from the customer indicated the device was used for an abscess in both pts cheeks, the procedure being performed was an i&d abscess with drain placement and a two week indwelling time for the malecot catheters. The tip portion of the device remained inside the cheek of the pts and was removed through and open incision using a knife, scissors, adson tissue forceps with teeth. No add'l procedures were needed due to the separation of the catheter tips. The instructions for use for this device states for "use to provide drainage following open renal and bladder surgeries. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2011-00015 |
| MDR Report Key | 2010490 |
| Report Source | 06 |
| Date Received | 2011-02-28 |
| Date of Report | 2011-02-25 |
| Report Date | 2011-01-26 |
| Date Mfgr Received | 2011-01-26 |
| Date Added to Maude | 2011-03-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 W. MORGAN |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE MALECOT CATHETER |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2011-02-28 |
| Returned To Mfg | 2011-02-01 |
| Model Number | NA |
| Catalog Number | 083808 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL INC |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-02-28 |