MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2013-02-13 for STOMAHESIVE STRIPS 025542 manufactured by Convatec.
[19691330]
Reported by the complainant as follows... Complaint received by (b)(4) team, also applies for 025542 lot 1l02643. Starting back in (b)(6) 2012, (b)(6) developed an ulcer in the peristomal area at about 3 o'clock. It is about 1 cm x 2 cm x 0. 2 cm with red moist wd bed and red to purplish edges. She has been seen by her dermatologist dr (b)(6) who is requesting the ingredients in both eakin seal and sh strip as she suspects an allergic reaction. Medical tx has seen dermatologist who suspects pyoderma granulosum ulcer was injected with steroids 2 weeks ago and (b)(6) applies clomex spray at each pouch change about q4days. Medical hx colostomy for perf divertic (b)(6) vasculitis ble about 1 yr ago. Arthritis meds see above clomex spray takes otc medications for arthritis allergies lidocaine adhesive tape gold environmental.
Patient Sequence No: 1, Text Type: D, B5
[19833801]
The medical determination is 'serious' because of the mention in the complaint narrative that the suspected diagnosis is: 'pyoderma gangrenosum'. Pyoderma gangrenosum is an uncommon, ulcerative cutaneous condition of uncertain etiology. It is associated with systemic diseases in at least 50% of patients who are affected. The diagnosis is made by excluding other causes of similar-appearing cutaneous ulcerations, including infection, malignancy, vasculitis, collagen vascular diseases, diabetes, and trauma. In a process termed pathergy, new ulcerations may occur after trauma or injury to the skin in 30% of patient who already have pyoderma gangrenosum. (culled from a medscape article). It is unlikely that trauma to the skin from the eakin cohesive seals/skin barrier has led to this condition. A more biologically plausible explanation for this event is the fact that the patient was reported to have been treated last year for vasculitis (a systemic medical condition that can give similar skin symptoms as pyoderma gangrenosum). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2013-00007 |
| MDR Report Key | 2967992 |
| Report Source | 01,06,07 |
| Date Received | 2013-02-13 |
| Date of Report | 2013-01-17 |
| Date of Event | 2012-11-01 |
| Date Mfgr Received | 2013-01-17 |
| Date Added to Maude | 2013-02-20 |
| 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 | KATRINA FIELDER |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042541 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOMAHESIVE STRIPS |
| Generic Name | PROTECTOR/OSTOMY |
| Product Code | EZR |
| Date Received | 2013-02-13 |
| Model Number | NA |
| Catalog Number | 025542 |
| Lot Number | 1L02643 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2013-02-13 |