MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07,company representative, report with the FDA on 2013-11-22 for ALOE VESTA PERINEAL/SKIN CLEANSER 324709 manufactured by Convatec Inc..
[3964964]
End user's wife reported issue with pain and burning after aloe vesta perineal skin cleanser was used. The end user's wife stated that the end user described pain and burning up to one hour after application. He was able to remove the product from the skin with a wash cloth and water. The pain and burning then stopped. He tried a second time and he had a similar experience.
Patient Sequence No: 1, Text Type: D, B5
[11353748]
Based on the available info, this event is deemed a serious injury. It was recommended for the end user to discontinue use of the product. No additional patient/event details have been provided to date. A return sample for evaluation is not expected. Should additional info become available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[51081334]
Additional information was received on june 15, 2015. Third party manufacturer performed a batch record review for lot# g2e104 which showed that all processes were followed in the production of the batch and in packaging. All finished bulk and finished goods met specifications. Testing of the retain samples showed that the product was acceptable. It is concluded that the complaint issue was not caused by the manufacturing of the product or the 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 issue 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 | 2243969-2013-00234 |
| MDR Report Key | 3506098 |
| Report Source | 04,07,COMPANY REPRESENTATIVE, |
| Date Received | 2013-11-22 |
| Date of Report | 2013-10-24 |
| Date of Event | 2013-10-21 |
| Date Mfgr Received | 2013-10-24 |
| Device Manufacturer Date | 2012-05-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARY SZARO, ASSOC. 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 | 2013-11-22 |
| Model Number | 324709 |
| Catalog Number | 324709 |
| Lot Number | G2E104 |
| Device Expiration Date | 2017-05-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC. |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-22 |