MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-04-11 for SPENCO MEDICAL CORP. * 46-524-02 manufactured by Spenco Medical Corp..
[18601711]
Pt used co's hot wrap, which is a hot compress type device. She says that she used it according to instructions but that the device still burned her leaving a permanent scar on her left shoulder which is approx. 3 inches long and will require cosmetic surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1619779-1997-00001 |
| MDR Report Key | 83103 |
| Report Source | 00 |
| Date Received | 1997-04-11 |
| Date of Report | 1995-04-11 |
| Date of Event | 1995-04-07 |
| Date Mfgr Received | 1997-04-09 |
| Device Manufacturer Date | 1986-01-01 |
| Date Added to Maude | 1997-04-15 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPENCO MEDICAL CORP. |
| Generic Name | HOT COMPRESS |
| Product Code | IMA |
| Date Received | 1997-04-11 |
| Model Number | * |
| Catalog Number | 46-524-02 |
| Lot Number | NA (CLASS I EXEMPT) |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 82452 |
| Manufacturer | SPENCO MEDICAL CORP. |
| Manufacturer Address | 6301 IMPERIAL DR. PO BOX 2501 WACO TX 76702 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-04-11 |