MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-12-11 for ALLKARE ADHESIVE REMOVER WIPE 037443 manufactured by Aphena Pharma Solutions Inc..
[33272586]
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
[33272587]
Complainant reports "initial stinging sensation on initial use, then rash developed over the next 48 hrs. Presented to the emergency department and was given antihistamines. " patient was treated with iv toramycin & iv merapenum, nebulised colistin &nebulised tobramycin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1130591-2015-40110 |
| MDR Report Key | 5289124 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-12-11 |
| Date of Report | 2015-11-06 |
| Date Mfgr Received | 2015-11-06 |
| Device Manufacturer Date | 2012-07-19 |
| 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 | ALLKARE ADHESIVE REMOVER WIPE |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2015-12-11 |
| Model Number | 037443 |
| Lot Number | 12201A |
| Device Expiration Date | 2017-07-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APHENA PHARMA SOLUTIONS INC. |
| Manufacturer Address | 7978 INDUSTRIAL PARK ROAD EASTON MD 21601 US 21601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-11 |