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..
[27101040]
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. Blank fields on this form indicate the information is unknown, unavailable or unchanged. 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
[27101041]
It was reported that the patient felt pain immediately upon application for an extended period of time, because of that it has been necessary the use of anti-inflammatory to relieve the discomfort.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518467-2015-30108 |
| MDR Report Key | 5113216 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2015-09-30 |
| Date of Report | 2014-02-27 |
| Date of Event | 2012-02-01 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2011-04-03 |
| 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 | 0971A1 |
| Device Expiration Date | 2013-04-02 |
| 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 |