MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2001-11-08 for SINGLE DISP TRANSPAC IV TRANSDUCER 42620 manufactured by Abbott Laboratories.
[236836]
Report received from abbott international affiliate (abbott japan) of a cracked transducer with bleed back. The report states: "it was noticed that rubber of squeeze flush had cracked and blood diffused in filler solution. There is no harm to the pt. " additional info was requested, but no further info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713468-2001-00041 |
| MDR Report Key | 360620 |
| Report Source | 01,05,07 |
| Date Received | 2001-11-08 |
| Date of Report | 2001-10-03 |
| Date of Event | 2001-10-01 |
| Date Mfgr Received | 2001-10-03 |
| Date Added to Maude | 2001-11-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | FRANK POKROP ASSOCIATE DIRECTOR |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPARTMENT 37K,AP30 |
| Manufacturer City | ABBOTT PARK IL 600646157 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646157 |
| Manufacturer Phone | 8479378473 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE DISP TRANSPAC IV TRANSDUCER |
| Generic Name | PRESSURE MONITORING KIT |
| Product Code | BYR |
| Date Received | 2001-11-08 |
| Model Number | NA |
| Catalog Number | 42620 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 349792 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 4455 ATHERTON SALT LAKE CITY UT 84123 US |
| Baseline Brand Name | SINGLE DISP TRANSPAC IV TRANSDUC |
| Baseline Generic Name | PRESSURE MONITORING KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 42620 |
| Baseline ID | NA |
| Baseline Device Family | MONITOR, BP, TRANSDUCER, NON-INDWELLING |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K932188 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-11-08 |