MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-22 for KLING * 6930 manufactured by Johnson & Johnson Medical Inc..
[186076]
During dressing change a black spot was noted on dressing near the end of the roll. The complete bandage was removed immediately. New roll of bandage used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019761 |
| MDR Report Key | 292053 |
| Date Received | 2000-08-22 |
| Date of Report | 2000-08-16 |
| Date of Event | 2000-06-11 |
| Date Added to Maude | 2000-08-25 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | KLING |
| Generic Name | FLUFF ROLL BANDAGE |
| Product Code | EFN |
| Date Received | 2000-08-22 |
| Returned To Mfg | 2000-06-28 |
| Model Number | * |
| Catalog Number | 6930 |
| Lot Number | 200013610304 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 282669 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL INC. |
| Manufacturer Address | 2500 E ARBROOK AVE PO BOX 90130 ARLINGTON TX 76014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-08-22 |