MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-05-29 for UNK manufactured by Johnson & Johnson Medical, Inc..
[96502]
Service rep alleges developing injuries from prolonged exposure to the fumes of glutaraldehyde.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1618732-1998-00138 |
| MDR Report Key | 169655 |
| Report Source | 00 |
| Date Received | 1998-05-29 |
| Date of Report | 1998-05-18 |
| Date Mfgr Received | 1998-05-18 |
| Date Added to Maude | 1998-06-01 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | GLUTARALDEHYDE |
| Product Code | IFT |
| Date Received | 1998-05-29 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 165028 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL, INC. |
| Manufacturer Address | 2500 ARBROOK BLVD. ARLINGTON TX 760143899 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 1998-05-29 |