MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-11-18 for ALOE VESTA - ALOE VESTA PERINEAL/SKIN CLNSR 324709 manufactured by Convatec, Inc..
[4105470]
The director of nursing called in and stated an aide accidently sprayed the product in their eyes and proceeded to rinse out their eyes in the eye wash area. The director of nursing went on to state the aides' eyes were still burning.
Patient Sequence No: 1, Text Type: D, B5
[11269279]
Based on the available information, this event is deemed a serious injury. The aid was advised to continue flushing their eyes and if the burning persisted to seek medical care. The director of nursing also stated they did not have time to give any additional information and was informed to call back at a more convenient time. On november 15, 2013 follow-up information was obtained from the facility regarding the aide. The director of nursing stated, the aid was fine after increased flushing and did not seek other medical care. No additional pt/event details have been provided to date. Should additional information become available, a follow-up report will be submitted. A return sample for evaluation is not expected. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2013-00217 |
| MDR Report Key | 3503315 |
| Report Source | 05,06,07 |
| Date Received | 2013-11-18 |
| Date of Report | 2013-10-18 |
| Date of Event | 2013-10-18 |
| Date Mfgr Received | 2013-10-18 |
| Date Added to Maude | 2013-12-09 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY SZARO, ASSOCIATE DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALOE VESTA - ALOE VESTA PERINEAL/SKIN CLNSR |
| Generic Name | SKIN CLEANSER |
| Product Code | KOY |
| Date Received | 2013-11-18 |
| Model Number | 324709 |
| Catalog Number | 324709 |
| Lot Number | UNK |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC, INC. |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-18 |