MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-23 for SAF-GEL US 145730 manufactured by Accupac, Inc..
[26845133]
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).
Patient Sequence No: 1, Text Type: N, H10
[26845134]
It was reported that "when the tap was taken off the tube, the customer realized that the tap seemed to be rusted. We have received the unit and took off the tap and verified that the tube internally is also rusted. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518467-2015-30164 |
| MDR Report Key | 5097426 |
| Date Received | 2015-09-23 |
| Date of Report | 2014-02-27 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2011-04-06 |
| Date Added to Maude | 2015-09-23 |
| 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 | 0 |
| Brand Name | SAF-GEL US |
| Generic Name | DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC |
| Product Code | NAE |
| Date Received | 2015-09-23 |
| Model Number | 145730 |
| Lot Number | 1011A1 |
| Device Expiration Date | 2013-04-05 |
| 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. MAINLAND PA 19451 US 19451 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-23 |