MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2014-08-01 for STOMAHESIVE PASTE 183910 manufactured by Convatec Inc..
[4729285]
Report received indicated that the patient was prescribed an ostomy paste to use on a "diabetic-type" ulceration in order to ensure a proper seal with a wound vacuum. After a few hours, the patient reported they began to feel "strange, uneasy, anxious and paranoid and started to have mild hallucinations and/or delusions. The patient reportedly received medical intervention; however, no details regarding the nature of the treatment rendered were provided. No further patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12010115]
Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filling this report shall be filed on a supplemental mdr. Twelve months of complaint history data was reviewed for this product icc. Based on the review, (b)(4) cases were registered for allergic reaction with icc number (b)(4) within the previous 12 months. Convatec will continue to monitor these complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2014-10407 |
| MDR Report Key | 4039807 |
| Report Source | 00,07 |
| Date Received | 2014-08-01 |
| Date of Report | 2011-12-16 |
| Date of Event | 2011-09-07 |
| Date Mfgr Received | 2011-12-16 |
| Date Added to Maude | 2014-08-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, DIRECTOR, ENG. |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOMAHESIVE PASTE |
| Generic Name | PROTECTOR, OSTOMY |
| Product Code | EZR |
| Date Received | 2014-08-01 |
| Model Number | 183910 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC. |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2014-08-01 |