MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-13 for PLAZLYTE STERILIZER UNK manufactured by Abtox.
[97030]
According to the rptr, she rec'd a call from the clinical educator at abtox. The rptr was informed to stop processing instruments used for eye surgical procedures in the plazlyte sterilizer. Reportedly, a hosp had 6-8 pts develop complications following eye surgery. The complications might be related to the sterilization process. Since the rptr's facility has experienced no problems of this nature, she wishes to continue using this sterilization method. She feels the key to avoiding complications is to strictly adhere to the mfr's recommended practices/procedures. She is seeking fda's guidance on using this method of sterilization for instruments used during eye surgial procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013482 |
| MDR Report Key | 162019 |
| Date Received | 1998-04-13 |
| Date of Report | 1998-04-13 |
| Date of Event | 1998-04-13 |
| Date Added to Maude | 1998-04-14 |
| 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 | PLAZLYTE STERILIZER |
| Generic Name | ETHYLENE-OXIDE GAS STERILIZER |
| Product Code | FLF |
| Date Received | 1998-04-13 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 157755 |
| Manufacturer | ABTOX |
| Manufacturer Address | 104 PARIS DR. MUNDELEIN IL 600603826 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-04-13 |