MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-06-04 for SENSI-CARE STING FREE PROTECTIVE SKIN BARRIER 420797 manufactured by Convatec, Inc..
[4674373]
It is reported that the patient was having an allergic reaction to the sensi-care skin barrier product. The nurse was using this product to protect the skin under the wound vac dressing. The doctor ordered to discontinue the sensi-care protective barrier and apply anti-fungal powder to the affected area. The patient was also being treated for a systematic yeast infection, including oral thrush. The rash improved prior to discharge from the facility. The nurse states that it probably wasn't a rash but likely related to the yeast infection. The rash improved when they stopped using the sensi-care barrier, but this is also at the same time the patient was treated systemically and topically with antifungal medication.
Patient Sequence No: 1, Text Type: D, B5
[12020562]
Based on the available information, this event is deemed to be a serious injury. It is reported that rn treated the rash with anti-fungal medication and reports the rash went away. She then used 3m cavilon protective barrier. Three (3) attempt made to ascertain additional information from nurse; left voice message to return call to (b)(4). First call was successful in reaching nurse but she was not able to give information at that time as she was at a patient's bedside delivering care. Two voice messages left with territory manager requesting facility contact information. Lastly, no returned calls and no replacement product sent. No additional patient/event details have been provided to date. A return sample for evaluation is not expected. Should additional information become available, a follow-up report will be submitted. Note: the actual date of event is unknown, so the date used was the date convatec became aware. Convatec will continue to track and monitor such complaints according to convatec inc's. Complaint handling and capa procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2014-00164 |
| MDR Report Key | 3888031 |
| Report Source | 05,06,07 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-05-07 |
| Date of Event | 2014-05-07 |
| Date Mfgr Received | 2014-05-07 |
| Date Added to Maude | 2014-06-24 |
| 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 | 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 | 3 |
| Brand Name | SENSI-CARE STING FREE PROTECTIVE SKIN BARRIER |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTARANT |
| Product Code | NEC |
| Date Received | 2014-06-04 |
| Model Number | 420797 |
| Catalog Number | 420797 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| 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 | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-04 |