MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2015-12-11 for SAF-GEL (12TUBEX3OZ) 145730 manufactured by Accupac, Inc.
[33280949]
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4) and protocol (b)(4). 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
[33280950]
Complainant reported "after seven days using the product, he noticed the color change of the wound (turned green), and presence of foul odor. The nurse identified presence of bacteria in the wound edge. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518467-2015-40036 |
| MDR Report Key | 5289616 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2015-12-11 |
| Date of Report | 2015-11-06 |
| Date Mfgr Received | 2015-11-06 |
| Date Added to Maude | 2015-12-11 |
| 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 | 7900 TRIAD CENTER DRIVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAF-GEL (12TUBEX3OZ) |
| Generic Name | DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC |
| Product Code | NAE |
| Date Received | 2015-12-11 |
| Model Number | 145730 |
| 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 | 1. Required No Informationntervention | 2015-12-11 |