MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-11 for SEPTI-SOFT CONCENTRATE 325304 manufactured by Accupac, Inc.
[33277219]
Convatec is submitting this report as a result of activities related to convatec remediation 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
[33277220]
Complainant reports "(b)(6) male patient, post surgery from sinus surgery, with burning of both eyes. Ent surgeon used septisoft concentrate undiluted to cleanse nose prior to surgery. Septisoft ran down into patients eyes and was retained there for approx 2 hours until surgery was over. Operating room nurse was notified of patients eyes burning while patient was in outpatient setting preparing to go home. Surgery was today at approx 1230pm. Ent surgeon ordered eye ointment (tobramycin). " advised or nurse to irrigate eyes until soap is removed and to call if further questions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518467-2015-40076 |
| MDR Report Key | 5289432 |
| Report Source | HEALTH PROFESSIONAL |
| 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 |
| 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 | SEPTI-SOFT CONCENTRATE |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2015-12-11 |
| Model Number | 325304 |
| Operator | HEALTH PROFESSIONAL |
| 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 |