MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-06 for MULTIPURPOSE DRAINAGE CATHETER 10.2 FR, 25 CM G09502 ULT10.2-38-25-P-6S-CLM-RH manufactured by William Cook.
[44999471]
Patient was being treated for a pelvic abscess. In interventional radiology, the drain in question was placed on (b)(6) 2016. The patient returned to er on (b)(6) 2016 for removal of the drain as her condition had improved. At this time, the er physician attempted removal of the drain and had difficulty. He described that the suture that this drain has along its shaft became "stuck" and despite various attempts/methods to remove it (suture) were unsuccessful. The er physician stated that he has completed many of these procedures and has never had this happen when all or part of the suture is retained in the patient post procedure. The patient was successfully discharged with a course of oral antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062187 |
| MDR Report Key | 5646266 |
| Date Received | 2016-05-06 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-04-16 |
| Date Added to Maude | 2016-05-11 |
| 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 | MULTIPURPOSE DRAINAGE CATHETER 10.2 FR, 25 CM |
| Generic Name | MULTIPURPOSE DRAINAGE CATHETER |
| Product Code | NHC |
| Date Received | 2016-05-06 |
| Model Number | G09502 |
| Catalog Number | ULT10.2-38-25-P-6S-CLM-RH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK |
| Manufacturer Address | DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-06 |