MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2015-10-02 for DUODERM. HYDROACTIVE STERILE GEL 187987 manufactured by Convatec Limited.
[27354186]
Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro. Convatec is submitting this report pursuant to the provisions of 21cfr part 803. Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[27354187]
Complainant states: patient's son informed us that his mother uses duoderm hydroactive gel and felt pain. His mother has used the device since 2013. His mother needed to go to hospital to remove the gel. Hospital nurse removed the gel and applied the same device but different lot. The patient doesn't feel pain anymore.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2015-30221 |
| MDR Report Key | 5123801 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2015-10-02 |
| Date of Report | 2014-02-27 |
| Date of Event | 2014-07-07 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2015-10-02 |
| 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 | 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 | 3 |
| Brand Name | DUODERM. HYDROACTIVE STERILE GEL |
| Generic Name | DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC |
| Product Code | NAE |
| Date Received | 2015-10-02 |
| Model Number | 187987 |
| Lot Number | 3H02261 |
| Device Expiration Date | 2016-08-01 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH52NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-02 |