MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-11-09 for ALOE VESTA 2N1 BODY WASH/SHMP 324609 manufactured by Sysco Guest Supply Llc.
[30734714]
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4). Convatec is submitting this report pursuant to the provisions of 21cfr part 803. Blank fields on this form indicate the information is unknown, unavailable or unchanged. Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
Patient Sequence No: 1, Text Type: N, H10
[30734715]
Complainant reports "end user has been using sensicare septi soft concentrate with no issues and ordered new formulation and after 1 day developed splotchy itchy rash, red in color, hive like, and red over entire body. Reports no change in any diet or laundry detergent or meds. States used product 3 times over 10 days and then discontinued. Will give antihistamine. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249180-2015-31301 |
| MDR Report Key | 5210859 |
| Report Source | CONSUMER |
| Date Received | 2015-11-09 |
| Date of Report | 2014-02-27 |
| Date of Event | 2014-02-24 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2015-11-09 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEANETTE JOHNSON |
| Manufacturer Street | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3362973009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALOE VESTA 2N1 BODY WASH/SHMP |
| Generic Name | SKIN CLEANSER |
| Product Code | KOY |
| Date Received | 2015-11-09 |
| Model Number | 324609 |
| Lot Number | CSX2099C |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSCO GUEST SUPPLY LLC |
| Manufacturer Address | 309 KENNEDY DR SAYREVILLE NJ 08872 US 08872 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-09 |