MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2009-01-30 for ESTEEM SYNERGY STOMAHESIVE SKN BARRIER W/FLNG 405458 manufactured by Convatec.
[984423]
Reported by the complainant as follows... Customer reports he has experienced leakage under his appliance since surgery in late 2008. He was seen in the emergency room earlier today and was admitted into the hospital with a 2nd degree alkaline burn in the peristomal area. Overall area is about 10 cm in diameter; red; raw with weeping and some bleeding. He reports it is very painful and burning.
Patient Sequence No: 1, Text Type: D, B5
[8160653]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2009-00003 |
| MDR Report Key | 1300443 |
| Report Source | 04,07 |
| Date Received | 2009-01-30 |
| Date of Report | 2009-01-09 |
| Date of Event | 2009-01-09 |
| Date Mfgr Received | 2009-01-09 |
| Date Added to Maude | 2009-02-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Manufacturer Street | . |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM SYNERGY STOMAHESIVE SKN BARRIER W/FLNG |
| Generic Name | PROTECTOR, OSTOMY |
| Product Code | EZS |
| Date Received | 2009-01-30 |
| Model Number | NA |
| Catalog Number | 405458 |
| Lot Number | 8F33648 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-01-30 |