MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-02-21 for FOLEY CATHETER, 16F SILVER DYND160416 manufactured by Medline Industries, Inc..
[17566902]
The catheter fell out and the balloon was found to be ruptured.
Patient Sequence No: 1, Text Type: D, B5
[17718214]
The balloon of the foley catheter was tested prior to insertion and performed as intended. Later, when the pt was repositioned in bed, the catheter fell out and the balloon was found to be ruptured. A new catheter was inserted. The pt developed slight hematuria after this incident. The lot number is not known and there is no sample to evaluate. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00016 |
| MDR Report Key | 3649380 |
| Report Source | 06 |
| Date Received | 2014-02-21 |
| Date of Report | 2014-02-12 |
| Date of Event | 2014-01-15 |
| Date Mfgr Received | 2014-01-16 |
| Date Added to Maude | 2014-02-28 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOLEY CATHETER, 16F SILVER |
| Product Code | NWR |
| Date Received | 2014-02-21 |
| Catalog Number | DYND160416 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-21 |