MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-11 for AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS 412012 manufactured by Convatec Dominican Republic Inc.
[180517700]
Based on the available information, this event is deemed to be a serious injury. No lot number is available. Although a photograph has been received, no evaluation will be conducted. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[180517701]
End user reports an? Allergic reaction to the aquacel ag surgical cover dressing. The dressing was placed to right knee after surgery (b)(6) 2020. She started to have itching under the border on the second (2nd) day. The surgeon wanted her to leave it on for ten (10) days. She removed it after nine (9) days on (b)(6) 2020. She states the border was a gooey mess and melted into her skin. She used alcohol to remove residual adhesive on the skin after removal. Reports redness, welting, and blistering under border of the dressing. States she has hives from ankle to mid-thigh. Reports edema to calf that started (b)(6) 2020, which she believes is part of the reaction to the dressing. She has applied over the counter 1% hydrocortisone cream and taken over the counter benadryl with little improvement noted yet. Preparation of the skin prior to application of the dressing is unknown. Dermabond was used on the incision. A video and photographs were provided by the complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9618003-2020-01271 |
| MDR Report Key | 9696089 |
| Report Source | CONSUMER |
| Date Received | 2020-02-11 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-11 |
| 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 | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | CONVATEC DOMINICAN REPUBLIC INC |
| Manufacturer Street | KM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA |
| Manufacturer City | SAN CRISTOBAL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2020-02-11 |
| Model Number | 412012 |
| Catalog Number | 412012 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC DOMINICAN REPUBLIC INC |
| Manufacturer Address | KM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA SAN CRISTOBAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |