MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-01 for WOUND-UNKOWN WOUND CARE-UNKNOWN manufactured by Convatec.
[137662192]
Aquacel/ aquacel ag surgical cover dressing. Based on the available information, this event is deemed to be a reportable malfunction. No lot number is available. 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. Additional information has been requested, however to date no additional information has been received. The lot number was not provided. Therefore, we are unable to determine the specific manufacturing site.? Two (2)? Potential manufacturing site numbers are listed below.? Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[137662193]
It was reported a patient developed blistering within one week while using the aquacel dressing after a total knee arthroplasty and was readmitted to the hospital. No further patient or treatment details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2019-00144 |
| MDR Report Key | 8383731 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-01 |
| Date Mfgr Received | 2019-01-24 |
| Date Added to Maude | 2019-03-01 |
| 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 G1 | CONVATEC |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WOUND-UNKOWN |
| Generic Name | DRESSING, WOUND, HYDROPHILIC |
| Product Code | NAC |
| Date Received | 2019-03-01 |
| Model Number | WOUND CARE-UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 7900 TRIAD CENTER DRIVE SUITE 400 GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-01 |