MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-05-01 for DELTA CAST CONFORMABLE PLASTER BANDAGE 6603 manufactured by Johnson & Johnson Consumer Products, Inc..
[85324]
Cast became glazed when rubbed and caused maceration of the skin on the pt's foot. Burns and blisters appeared on the pt following application of casting material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1998-00080 |
| MDR Report Key | 165351 |
| Report Source | 07 |
| Date Received | 1998-05-01 |
| Date of Report | 1998-05-01 |
| Date Mfgr Received | 1998-04-01 |
| Date Added to Maude | 1998-05-04 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTA CAST CONFORMABLE PLASTER BANDAGE |
| Generic Name | BANDAGE, CAST |
| Product Code | LGF |
| Date Received | 1998-05-01 |
| Model Number | NA |
| Catalog Number | 6603 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 160932 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. |
| Manufacturer Address | US ROUTE #1 NORTH BRUNSWICK NJ 08902 US |
| Baseline Brand Name | DELTA CAST CONFORMABLE PLASTER BANDAGE |
| Baseline Generic Name | BANDAGE, CAST |
| Baseline Model No | NA |
| Baseline Catalog No | 6603 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-05-01 |