MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-16 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp.
[19282754]
The customer alleged cidex opa solution leaked from the aer unit. There was a crack in one of the fittings on the reservoir. Advanced sterilization products (asp) contacted the customer: the customer experienced burning sensation in the eyes and on the face. The customer did not come into contact with the solution; he believed the vapor caused the reactions. The customer immediately went to an eye-wash station and rinsed his eyes and face. The customer did experience some blurriness but it has resolved. No medical care was sought. At the time of this communication, there was a slight irritation in the eyes and face. The customer does not plan to seek medical attention. No personal protective equipment (ppe) was worn during the event. An asp field service engineer (fse) went to the facility and assessed the unit.
Patient Sequence No: 1, Text Type: D, B5
[19342033]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00164 |
| MDR Report Key | 1553327 |
| Report Source | 05 |
| Date Received | 2009-11-16 |
| Date of Report | 2009-10-21 |
| Date of Event | 2009-10-21 |
| Date Mfgr Received | 2009-10-21 |
| Date Added to Maude | 2010-03-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GINNY STAMBERGER |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | MINNTECH CORP |
| Manufacturer Street | 14605 28TH AVE. NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2009-11-16 |
| Model Number | NA |
| Catalog Number | 20301 |
| Lot Number | NA |
| ID Number | PART #: NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINNTECH CORP |
| Manufacturer Address | MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-16 |