MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-08-08 for KENDALL 7006 manufactured by Tyco Healthcare/kendall.
[525778]
It was reported to tyco healthcare/kendall in july 11, 2006, that a customer had a problem with a foley catheter. The customer states the balloon on the catheter ruptured, during testing, prior to insertion in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2006-00030 |
| MDR Report Key | 768952 |
| Report Source | 06,07 |
| Date Received | 2006-08-08 |
| Date of Report | 2006-07-11 |
| Date Mfgr Received | 2006-07-11 |
| Date Added to Maude | 2006-10-13 |
| 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 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618488 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| Manufacturer Street | 9255 CUSTOMHOUSE STE A |
| Manufacturer City | SAN DIEGO CA 92173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL |
| Generic Name | PRECISION 400 URINE METER |
| Product Code | EYZ |
| Date Received | 2006-08-08 |
| Model Number | NA |
| Catalog Number | 7006 |
| Lot Number | 530553364 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 756807 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 9255 CUSTOMHOUSE PLAZA SAN DIEGO CA 92173 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-08 |