MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-03-21 for FOLEY CATHETER, 16F, SILVER DYND140216 manufactured by Medline Industries, Inc..
[4248571]
The catheter balloon ruptured and a new catheter was inserted.
Patient Sequence No: 1, Text Type: D, B5
[11759254]
The end user stated that while showering, the catheter's balloon ruptured and the catheter had to be replaced. The catheter had been inserted 10 days prior to the incident. No issues were identified during that time. The new catheter was inserted and no injury was reported. The sample was not returned for evaluation. No lot number was reported. We have not confirmed the issue or identified a root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00035 |
| MDR Report Key | 3716128 |
| Report Source | 04 |
| Date Received | 2014-03-21 |
| Date of Report | 2014-03-20 |
| Date of Event | 2014-02-24 |
| Date Mfgr Received | 2014-02-24 |
| Date Added to Maude | 2014-04-02 |
| 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 | 0 |
| 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 | 2014-03-21 |
| Catalog Number | DYND140216 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| 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 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-21 |