MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-03-26 for COMFORT WEAR LGS manufactured by The Marena Group, Inc..
[316893]
Company received a summons claiming that their garment caused the death of patient who had undergone liposuction. The garment was sold by distributer to medical center and prescribed by dr. Company has no further information. Facility stocked several brands of compression garments and company is not 100% certain company manufactured this product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062379-2003-00001 |
| MDR Report Key | 452311 |
| Report Source | 00 |
| Date Received | 2003-03-26 |
| Date of Report | 2003-03-24 |
| Date of Event | 2003-02-07 |
| Date Mfgr Received | 2003-02-07 |
| Date Added to Maude | 2003-04-09 |
| 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 | 650 PROGRESS IND. BLVD. |
| Manufacturer City | LAWERENCEVILLE GA 30043 |
| Manufacturer Country | US |
| Manufacturer Postal | 30043 |
| Manufacturer Phone | 6789901947 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMFORT WEAR |
| Generic Name | FEMALE GIRDLE |
| Product Code | MDR |
| Date Received | 2003-03-26 |
| Model Number | LGS |
| Catalog Number | LGS |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 441301 |
| Manufacturer | THE MARENA GROUP, INC. |
| Manufacturer Address | 650 PROGRESS INDUSTRIAL BLVD LAWRENCEVILLE GA 30043 US |
| Baseline Brand Name | COMFORTWEAR |
| Baseline Generic Name | FEMALE GIRDLE |
| Baseline Model No | LGS |
| Baseline Catalog No | LGS |
| Baseline ID | NA |
| Baseline Device Family | GIRDLES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2003-03-26 |