MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-03-25 for PERCLOSE * 83269-6H 2002/11 manufactured by Abbott Laboratories Comp.
[282109]
Perclose sutures failed to deploy in rfa post cath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024565 |
| MDR Report Key | 386309 |
| Date Received | 2002-03-25 |
| Date of Report | 2002-03-20 |
| Date of Event | 2002-03-20 |
| Date Added to Maude | 2002-04-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCLOSE |
| Generic Name | 6F CLOSER |
| Product Code | KGL |
| Date Received | 2002-03-25 |
| Model Number | * |
| Catalog Number | 83269-6H 2002/11 |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 2002-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 375343 |
| Manufacturer | ABBOTT LABORATORIES COMP |
| Manufacturer Address | 400 SAGINAW DR REDWOOD CITY CA 94063 US |
| Baseline Brand Name | ULTRALITE FULL BODY PHOTOTHERAPY UNIT |
| Baseline Generic Name | UV DERMATOLOGY LIGHT |
| Baseline Model No | V4824TL |
| Baseline Catalog No | V4824TL |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-03-25 |