MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-05-23 for AQUACEL FOAM 420636 manufactured by Convatec Inc.
[145967072]
Based on the available information, this event is deemed to be a serious injury. Additional patient/event details have been requested but not provided to date. Should additional information become available a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145967073]
It was reported the "aquacel inside of foam cannot absorb exudate properly". The dressing was reported to be changed every third day which end user alleges led primarily to maceration as well as necrosis that occurred on a small wound area. The treating physician noticed a change in the wound but, was unable to confirm when the change occurred. The patient did not have any serious problems that required medical treatment other than debridement of the affected area. Per the information provided, the end user has multiple wounds with multiple dressings used from multiple lots. The total amount of dressings related to the maceration and necrosis is still unknown. Photographs of the product were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2019-00199 |
| MDR Report Key | 8637304 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-05-23 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-23 |
| 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 | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | CONVATEC INC |
| Manufacturer Street | 211 AMERICAN AVENUE |
| 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 | AQUACEL FOAM |
| Generic Name | DRESSING,WOUND,HYDROPHILIC |
| Product Code | NAC |
| Date Received | 2019-05-23 |
| Model Number | 420636 |
| Lot Number | 2673620 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC |
| Manufacturer Address | 211 AMERICAN AVENUE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-23 |