MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-03 for ALOE VESTA PERINEAL/SKIN CLEANSER 324709 manufactured by Convatec, Inc..
[17387007]
Nurse reported that resident ingested product today ((b)(6) 2013) at 10:00 am. It is also reported that end-user was given a drink of water, which resolved the issue resulting in no further complaint from end-user. Reporter states that there were no untoward effects noted to pt.
Patient Sequence No: 1, Text Type: D, B5
[17744098]
Based on the available information, this event is deemed a serious injury. It is reported that end-user was given a drink of water by nursing home staff, which resulted in no further complaint from end-user. Nursing home staff was advised to call a doctor and/or poison control center. In addition, a material safety data sheet (msds) was faxed to nursing home staff ((b)(6)), and were instructed to contact convatec with any questions, concerns or further issues. An investigation request was sent to the manufacturer on november 08, 2013. No additional pt/event details have been provided to date. A return sample for evaluation is not expected. Should additional information becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2013-00259 |
| MDR Report Key | 3523199 |
| Report Source | 05,07 |
| Date Received | 2013-12-03 |
| Date of Report | 2013-11-05 |
| Date of Event | 2013-11-05 |
| Date Mfgr Received | 2013-11-05 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2013-12-18 |
| 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 DRIVE |
| 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 PERINEAL/SKIN CLEANSER |
| Generic Name | SKIN CLEANSER |
| Product Code | KOY |
| Date Received | 2013-12-03 |
| Model Number | 324709 |
| Catalog Number | 324709 |
| Lot Number | G3E112 |
| Device Expiration Date | 2018-05-28 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2013-12-03 |