MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,08 report with the FDA on 1999-05-24 for ACUFEX, MOSAIC PLASTY-TUBULAR CHISEL 3.5MM 7207098 manufactured by Smith & Nephew Inc. Endoscopy Division.
[156857]
It was reported that when the surgeon used the device to harvest bone plug, he found that the plug was discolored. Surgeon cleaned the plug prior to inserting it into the pt. No pt injury has resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-1999-00033 |
| MDR Report Key | 225327 |
| Report Source | 01,05,07,08 |
| Date Received | 1999-05-24 |
| Date of Event | 1999-03-19 |
| Date Mfgr Received | 1999-04-26 |
| Device Manufacturer Date | 1998-11-01 |
| Date Added to Maude | 1999-06-02 |
| 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 | 3 |
| 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 CHISLE |
| Product Code | KDG |
| Date Received | 1999-05-24 |
| Returned To Mfg | 1999-05-14 |
| Model Number | NA |
| Catalog Number | 7207098 |
| Lot Number | 365009 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 218507 |
| Manufacturer | SMITH & NEPHEW INC. ENDOSCOPY DIVISION |
| 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 | 1999-05-24 |