MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for IRIDRESS SLEEVE IRRIG 175619 manufactured by Convatec Dominican Republic, Inc.
[27911758]
Convatec is submitting this report as a result of activities related to convatec remediation (b)(4). Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
Patient Sequence No: 1, Text Type: N, H10
[27911759]
It was reported from (b)(6) that "patient developed severe eczema (similar to 2nd degree burn) from product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9618003-2015-30391 |
| MDR Report Key | 5138972 |
| Date Received | 2015-10-08 |
| Date of Report | 2014-02-27 |
| Date of Event | 2013-08-19 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2015-10-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEANETTE JOHNSON |
| Manufacturer Street | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3362973009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IRIDRESS SLEEVE IRRIG |
| Generic Name | IRRIGATOR, OSTOMY |
| Product Code | EXD |
| Date Received | 2015-10-08 |
| Model Number | 175619 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC DOMINICAN REPUBLIC, INC |
| Manufacturer Address | 18.5 PARQUE INDUSTRIAL HAINA, SAN CRISTOBAL 33102 DR 33102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-08 |