MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2013-09-19 for SUR-FIT NATURE 2 PC DURAHESIVE CONVEX MOLDABLE 413177 manufactured by Convatec, Inc..
[3930520]
End user reports that they applied the product on skin, and developed an itch under the water's tape border within 12 hours after application. Upon removal of the product, they experienced itching and noticed redness at the affected site.
Patient Sequence No: 1, Text Type: D, B5
[11087707]
Based on the available info, this event is deemed a serious injury. From a clinical perspective, a causal relationship between the sur-fit natura 2 pc durahesive convex wafer and this event is deemed possible because the product in use is temporally associated with the skin where the problem occurred. According to the end-user, the skin is cleansed with dove soap and water, then applies eakin seal and barrier to the area. The product has been discontinued from use. No add'l event/pt details have been provided to date. A return sample for eval is not expected. Reported to the fda on (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2013-00027 |
| MDR Report Key | 3367052 |
| Report Source | 04,05,07 |
| Date Received | 2013-09-19 |
| Date of Report | 2013-08-21 |
| Date of Event | 2013-08-20 |
| Date Mfgr Received | 2013-08-21 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2013-09-26 |
| 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 |
| 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 | SUR-FIT NATURE 2 PC DURAHESIVE CONVEX MOLDABLE |
| Generic Name | PROTECTOR, OSTOMY |
| Product Code | EZS |
| Date Received | 2013-09-19 |
| Model Number | 413177 |
| Catalog Number | 413177 |
| Lot Number | 3C01115 |
| Device Expiration Date | 2018-03-24 |
| 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 | 2013-09-19 |