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 |