MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-11-20 for ALOE VESTA- PERINEAL/SKIN CLEANSER 324709 manufactured by Convatec, A Division Of E.r. Squibb & Sons, L.l.c..
[17282541]
The caregiver of an end user called in and stated the end user sprayed two (2) sprays of the product into her mouth.
Patient Sequence No: 1, Text Type: D, B5
[17621847]
Based on the available info this event is deemed a serious injury. The care giver of the end user stated the end user rinsed her mouth out with water. The material safety data sheet (msds) info for ingestion of the product was reviewed and the end user was advised to call poison control or follow up with a doctor. No add'l patient/event details have been provided to date. Should add'l info become available a follow-up report will be submitted. A return sample for eval is not expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2013-00224 |
| MDR Report Key | 3506135 |
| Report Source | 04,07 |
| Date Received | 2013-11-20 |
| Date of Report | 2013-10-22 |
| Date of Event | 2013-10-22 |
| Date Mfgr Received | 2013-10-22 |
| Date Added to Maude | 2013-12-11 |
| 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 DIR |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Manufacturer G1 | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALOE VESTA- PERINEAL/SKIN CLEANSER |
| Generic Name | SKIN CLEANSER |
| Product Code | KOY |
| Date Received | 2013-11-20 |
| Model Number | 324709 |
| Catalog Number | 324709 |
| Lot Number | G30109 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-20 |