MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-29 for LATEX FOLEY CATHETER DYND16011H manufactured by Medline Industries, Inc..
[5132815]
The balloon would not deflate and was manually ruptured by the physician.
Patient Sequence No: 1, Text Type: D, B5
[12768595]
Following an outpatient back surgery, when attempting to remove the catheter, the balloon would not deflate. The staff tried to deflate the balloon with a syringe and also cut the catheter, but the balloon would not passively deflate. A urologist came and ruptured the balloon using a guide wire. The catheter was removed without further incident. The sample was not returned for eval. We have no lot number. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00111 |
| MDR Report Key | 4320497 |
| Report Source | 05,06 |
| Date Received | 2014-11-29 |
| Date of Report | 2014-11-25 |
| Date of Event | 2014-10-31 |
| Date Mfgr Received | 2014-10-31 |
| Date Added to Maude | 2014-12-12 |
| 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 | LATEX FOLEY CATHETER |
| Product Code | NWR |
| Date Received | 2014-11-29 |
| Catalog Number | DYND16011H |
| 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 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-29 |