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 2014-07-07 for SENSI-CARE STING FREE PROTECTIVE SKIN BARRIER 413501 manufactured by Convatec Inc..
[20861705]
It is reported that after applying the sensi care sting free protective skin barrier under the aquacel foam dressing the end-user developed a red tender area around the wound on the buttocks. It is further reported that the product was in use for two (2) days before the incident occurred.
Patient Sequence No: 1, Text Type: D, B5
[21277090]
Based on the available information, this event is deemed as a serious injury. Further information has been requested from ((b)(6), nurse manager at (b)(6)) regarding any treatment for this issue and the patient outcome. No response to the requests has been received at this time. 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. 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 | 1049092-2014-00269 |
| MDR Report Key | 3946280 |
| Report Source | 05,06,07 |
| Date Received | 2014-07-07 |
| Date of Report | 2014-06-11 |
| Date of Event | 2014-06-08 |
| Date Reported to FDA | 2014-07-07 |
| Date Mfgr Received | 2014-06-11 |
| Date Added to Maude | 2014-07-22 |
| 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 | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, INT ASSOC DIR |
| Manufacturer Street | 211 AMERICAN AVENUE |
| 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 | 2014-07-07 |
| Model Number | 413501 |
| Catalog Number | 413501 |
| Lot Number | UNK |
| 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 | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-07 |