MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-17 for MEDIPEEL (ONE CANISTER) UNK manufactured by Saiode Soleil.
[225489]
Add'l info rec'd from rptr 11/24/00: when the machine tubes are clogged, a button must be pressed. When the user presses this button, all the particles are released into the atmosphere.
Patient Sequence No: 1, Text Type: D, B5
[16035997]
Add'l info rec'd from rptr 2/21/01: the use of one hose is causing cross-contamination of the particles.
Patient Sequence No: 1, Text Type: D, B5
[21253159]
Due to the poor design consisting of wood and only one compressor, the filtration process is inadequate. Rptr is concerned about infection because of aluminium oxide being released from the product without being sterilized. Rptr is also concerned about the lack of proper labeling. Rptr has had unsuccessful attempts in addressing the concerns to the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020452 |
| MDR Report Key | 316606 |
| Date Received | 2000-11-17 |
| Date of Report | 2000-11-17 |
| Date of Event | 2000-11-01 |
| Date Added to Maude | 2001-02-22 |
| 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 |
| 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 | MEDIPEEL (ONE CANISTER) |
| Generic Name | MICROEPIDERMAL SKIN SYSTEM |
| Product Code | GFE |
| Date Received | 2000-11-17 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 306145 |
| Manufacturer | SAIODE SOLEIL |
| Manufacturer Address | * VAN NUYS CA 91402 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-11-17 |