MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-08-07 for DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING 187659 manufactured by Convatec Limited.
[4864239]
Report received indicated the patient experienced blistering and skin breakdown with pain under dressing. Report also noted the patient experienced the adverse reaction over a period of four days due to a possible reaction to a film dressing product. The product was discontinued and the hydrocolloid dressing was applied. Patient is under care of home health nurse and has advised patient to discontinue use of duoderm and to use protective barrier wipe on skin. Patient outcome was not noted.
Patient Sequence No: 1, Text Type: D, B5
[12296915]
Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. A lot number could not be obtained; therefore, a review of the batch record data could not be performed without a valid lot number. A review of the complaint listing for the previous 12 months for this product icc code indicates that there were 2 complaint issues for the blister/breakdown under product at the time of this analysis. Convatec will continue to monitor these issues and process accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000317571-2014-10713 |
| MDR Report Key | 4061108 |
| Report Source | 04,07 |
| Date Received | 2014-08-07 |
| Date of Report | 2014-05-29 |
| Date Mfgr Received | 2014-05-29 |
| Date Added to Maude | 2014-09-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, DIRECTOR |
| 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 | DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING |
| Generic Name | OCCLUSIVE WOUND DRESSINGS |
| Product Code | MGP |
| Date Received | 2014-08-07 |
| Model Number | 187659 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-07 |