MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2014-08-14 for SENSI-CARE PROTECTIVE BARRIER manufactured by .
[52487370]
Based on the available information, this event is deemed a serious injury. No additional patient/event details have ben provided to date. A return sample for the evaluation is not expected. Should additional information become available, a follow-up report will be submitted. There are three (3) cases associated with this product, therefore a separate fda 3500a form has been generated to address the other two (2) cases. The actual date of event is unknown, so the date used was the date (b)(4) became aware. Continued from (c. 4. 2): product therapeutic indications are to temporarily protect and help relieve chapped or cracked skin and lips; to treat and prevent diaper rash; and protect minor skin irritation associated with diaper rash and to help seal out wetness. The lot number was not provided. Therefore, we are unable to determine the specific manufacturing site, thus both potential manufacturing site numbers are listed below. Reported to the fda on august 14, 2014.
Patient Sequence No: 1, Text Type: N, H10
[52487371]
The facility wound care manager reported that three (3) patient developed pressure ulcers to the sacra-buttock area. The wound care manager stated the product was being utilized for contact dermatitis in the sacral area dn the nurses were applying the protective barrier to wet moist areas. The depth of the pressure ulcers were assessed as stage iii or stage iv although it was reported the staff were having difficulty removing the product and were unable to assess the skin. The wound care manager did not indicate additional treatment for the pressure ulcers. The territory manager indicated the facility had elected to switch to a new product and were advised they had to used the product in stock before switching to the new product. He reported no safety issues was involved, however educational opportunities for the application of product, how to assess skin, and reapplication of the product were identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2014-00401 |
| MDR Report Key | 4023613 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2014-08-14 |
| Date of Report | 2014-07-23 |
| Date of Event | 2014-07-23 |
| Date Mfgr Received | 2014-07-23 |
| Date Added to Maude | 2014-08-20 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW WALENCIAK, INT.ASSOC.DIR. |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SENSI-CARE PROTECTIVE BARRIER |
| Generic Name | TOPICAL, OUNCE SIZE; QUANTITIY PER CASE: 24TUBES |
| Product Code | NEC |
| Date Received | 2014-08-14 |
| Lot Number | UNK |
| ID Number | NDC: 43553-3256-4 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-14 |