MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07,company represent report with the FDA on 2013-09-16 for ALOE VESTA - ALOE VESTA PERINEAL/SKIN CLNSR 324709 manufactured by Convatec Inc..
[21263017]
A male patient complained of a burning sensation when the incontinence cleanser was sprayed to buttock perineum area. Reporter states the staff member did not spray it too close to the patient stage ii pressure ulcer. She reports patient did have some weepy areas on skin related to incontinence. The patient was turned on his side and facing away from the staff member spraying the cleanser and also states the patient coughed due to the spray. Patient experienced a burning sensation to weepy skin and cough subsided and no treatment needed. Reporter denied getting any onto face and no eye burning irritation.
Patient Sequence No: 1, Text Type: D, B5
[21269606]
This is deemed a serious injury because medical intervention/treatment may be needed if this issue were to recur. The use of the aloe vesta perineal/skin cleanser is deemed possibly related to the event. According to the reporter, "no medical treatment was required or given" and they did not know a time frame of when the event occurred. No additional information has been provided to date. A return sample for evaluation is not expected. (b)(4). Note: the actual date of event is unknown, so the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
[51062732]
Additional information was received on june 15, 2015. Third party manufacturer performed a batch record review of lot# g3d108 which showed that all processes were followed during the production of the batch as well as packaging. All bulk and finished goods met specifications. Testing of the retain samples showed that the product is acceptable. It was concluded that the complaint issue was not due to the product or packaging. After a thorough batch record review, no discrepancies or non-conformances were discovered. There is not enough information to conclude the product did not meet specification and perform as intended. Product monitoring reviews will monitor for product trends if this were to reoccur. No further actions are required and the complaint will be closed. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2013-00085 |
| MDR Report Key | 3367681 |
| Report Source | 04,05,06,07,COMPANY REPRESENT |
| Date Received | 2013-09-16 |
| Date of Report | 2013-08-16 |
| Date of Event | 2013-08-16 |
| Date Mfgr Received | 2013-08-16 |
| Date Added to Maude | 2013-09-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARY SZARO |
| 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 | 2013-09-16 |
| Model Number | 324709 |
| Catalog Number | 324709 |
| Lot Number | G30108 |
| 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 | 1. Other | 2013-09-16 |