MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1997-04-04 for ACUFEX MOSAIC PLASTY-TUBULAR CHISEL 3.5MM 7207098 manufactured by Smith & Nephew, Inc. Endoscopy Div..
Report Number | 1219602-1997-00023 |
MDR Report Key | 82833 |
Report Source | 05,06,07 |
Date Received | 1997-04-04 |
Date of Event | 1997-03-06 |
Date Mfgr Received | 1997-03-10 |
Device Manufacturer Date | 1996-05-01 |
Date Added to Maude | 1997-04-14 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 0 |
Reprocessed and Reused Flag | 0 |
Health Professional | 0 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 0 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ACUFEX MOSAIC PLASTY-TUBULAR CHISEL 3.5MM |
Generic Name | BONE CHISEL |
Product Code | KDG |
Date Received | 1997-04-04 |
Model Number | NA |
Catalog Number | 7207098 |
Lot Number | 196 |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | * |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 82203 |
Manufacturer | SMITH & NEPHEW, INC. ENDOSCOPY DIV. |
Manufacturer Address | 130 FORBES BLVD. MANSFIELD MA 02048 US |
Baseline Brand Name | ACUFEX MOSAICPLASTY TUBULAR CHISEL 3.5MM |
Baseline Generic Name | BONE CHISEL |
Baseline Model No | NA |
Baseline Catalog No | 7207098 |
Baseline ID | LOT NUMBER 196 |
Baseline Device Family | MOSAICPLASTY |
Baseline Shelf Life [Months] | NA |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K962789 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1997-04-04 |