MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2015-09-30 for SAF-GEL 145730 manufactured by Accupac, Inc..
[27127869]
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
[27127870]
It was reported that the customer realized that the tap seemed to be rusted.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2518467-2015-30109 |
MDR Report Key | 5114008 |
Report Source | CONSUMER,FOREIGN |
Date Received | 2015-09-30 |
Date of Report | 2014-02-27 |
Date Mfgr Received | 2014-02-27 |
Device Manufacturer Date | 2011-08-11 |
Date Added to Maude | 2015-09-30 |
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 |
Reporter Occupation | PATIENT |
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 | SAF-GEL |
Generic Name | DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC |
Product Code | NAE |
Date Received | 2015-09-30 |
Model Number | 145730 |
Lot Number | 2241A2 |
Device Expiration Date | 2013-08-10 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ACCUPAC, INC. |
Manufacturer Address | 1501 INDUSTRIAL BLVD. PO BOX 200 MAINLAND PA 194510200 US 194510200 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2015-09-30 |