MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-11-26 for SENSI-CARE STING FREE PROTECTIVE SKIN BARRIER 413501 manufactured by Convatec Inc..
[3973653]
Customer reports burning sensation to the right lower quadrant of abdominal skin under where barrier wipe is applied, after 2 days of wear. Product was in use for 3 weeks and wear-time of appliance is 3-4 days.
Patient Sequence No: 1, Text Type: D, B5
[11303589]
Based on the available info, this event is deemed to be a serious injury. Further reports indicate that customer is using convatec's sur-fit natura stomahesive flexible skin barrier with cut-to-fit opening as well as stomahesive powder blotted with barrier wipe. End-user was advised to discontinue use of sting free barrier wipe and to contact his health care provider (hcp) for follow-up, and recommendation was verbally agreed by end-user. Lastly, end-user states that he has contacted his ostomy nurse and is scheduled to see her in 2 weeks. No additional patient/event details have been provided to date. A return sample for evaluation is not expected. Should additional info becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2013-00242 |
| MDR Report Key | 3514282 |
| Report Source | 04,07 |
| Date Received | 2013-11-26 |
| Date of Report | 2013-10-28 |
| Date of Event | 2013-10-14 |
| Date Mfgr Received | 2013-10-28 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2013-12-12 |
| 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 | MARY SZARO, ASSOC DIRECTOR |
| 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 | SENSI-CARE STING FREE PROTECTIVE SKIN BARRIER |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2013-11-26 |
| Model Number | 413501 |
| Catalog Number | 413501 |
| Lot Number | T606 |
| Device Expiration Date | 2017-03-01 |
| 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 | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-26 |