MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-07-01 for WARM-UP WOUND CARE SYSTEM 68048 (67448) 67448. manufactured by Augustine Medical, Inc..
[322397]
Pt wound was being treated with wound covers for 2 weeks when they developed cellulitus. Pt was hospitalized as a result. It is unclear if the cellulitus is attributed to the wound cover.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183725-2003-00002 |
| MDR Report Key | 469987 |
| Report Source | 05 |
| Date Received | 2003-07-01 |
| Date of Report | 2003-06-27 |
| Date of Event | 2003-05-31 |
| Date Facility Aware | 2003-05-31 |
| Report Date | 2003-06-03 |
| Date Reported to Mfgr | 2003-06-03 |
| Date Mfgr Received | 2003-06-03 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2003-07-09 |
| 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 |
| Manufacturer Street | 10393 WEST 70TH ST |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9529471200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WARM-UP WOUND CARE SYSTEM |
| Generic Name | WOUND MANAGEMENT |
| Product Code | MSA |
| Date Received | 2003-07-01 |
| Model Number | 68048 (67448) 67448. |
| Catalog Number | 68048 (67448) 67448. |
| Lot Number | 032902 (052402) 052402. |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 458833 |
| Manufacturer | AUGUSTINE MEDICAL, INC. |
| Manufacturer Address | 10393 WEST 70TH ST. EDEN PRAIRIE MN 55344 US |
| Baseline Brand Name | WARM-UP WOUND CARE SYSTEM |
| Baseline Generic Name | WOUND MANAGEMENT |
| Baseline Model No | 68048 (67448) 6 |
| Baseline Catalog No | 68048 (67448) 67448. |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2003-07-01 |