MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-30 for SILICONE MALECOT CATHETER manufactured by Cook Medical.
[35099694]
Pt was admitted to the surgery center for exam under anesthesia. Md determined that there was an anal fistula, fistulotomy performed, md requested silicone malecot catheter for placement, to be removed by md at a later date. Center was notified by the md that during removal of the catheter, the tip broke off and was left in the pt. The tip of the catheter had to be surgically removed. The center's purchasing coordinator notified qa manager and contacted the product mfr/ rep. All other silicone malecot catheters removed from stock at this time. Md notified surgery center of event the week of (b)(6) of the event. Dates of use: (b)(6) 2015 - (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058884 |
| MDR Report Key | 5344465 |
| Date Received | 2015-12-30 |
| Date of Report | 2015-12-30 |
| Date of Event | 2015-12-07 |
| Date Added to Maude | 2016-01-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE MALECOT CATHETER |
| Generic Name | SILICONE MALECOT CATHETER |
| Product Code | FEW |
| Date Received | 2015-12-30 |
| Lot Number | U2438296 |
| ID Number | G16923 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-30 |