MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2007-02-16 for SILICONE FOLEY CATHETER 5558605514 manufactured by Tyco Healthcare/kendall.
[15220433]
It was reported to tyco healthcare/kendall on january 17, 2007 that a customer had a problem with a foley catheter. The customer stated on the 14th day of use, the catheter was torn in two. A cystoscope was used to remove the remaining piece from the pt's body.
Patient Sequence No: 1, Text Type: D, B5
[15563739]
An investigation is currently underway. Upon its completion, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2007-00002 |
| MDR Report Key | 836616 |
| Report Source | 01,06 |
| Date Received | 2007-02-16 |
| Date of Report | 2007-01-17 |
| Date of Event | 2006-12-26 |
| Report Date | 2007-01-17 |
| Date Reported to Mfgr | 2007-01-17 |
| Date Mfgr Received | 2007-01-17 |
| Date Added to Maude | 2007-04-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA REGAN |
| Manufacturer Street | 15 HAMPHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618488 |
| Manufacturer G1 | TYCO HEALTHCARE/ KENDALL |
| Manufacturer Street | FABRICA BLVD INSURGENTES LA MESA |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE FOLEY CATHETER |
| Generic Name | FOLEY CATHETER |
| Product Code | FCN |
| Date Received | 2007-02-16 |
| Model Number | 5558605514 |
| Catalog Number | 5558605514 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Age | UNK |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 823911 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-16 |