MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-22 for AQUACEL/AQUACEL AG - EXUDATE MANAGEMENT HYDROFIBER DRESSING ROPE 403770 manufactured by Convatec Ltd.
[142639713]
(b)(6). 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. 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
[142639714]
It was reported the "aquacel ribbon disintegrated in an abdominal cavity wound - didn't come out of the cavity in one piece. There was a corrugated plastic drain in the cavity too. Around 15 centimeters? Length of the aquacel ribbon had been packed into the wound down the side of the corrugated drain and the remaining 30 centimeters had been laid over the top of the wound, the entire dressing had disintegrated including the stitching. Unable to remove the dressing easily and the corrugated drain had to be removed to allow nurse to irrigate the wound to remove all traces of the aquacel ribbon. " it was further reported? Aquacel? Ribbon dressing was removed by way of saline irrigation and the use of a wound swab to remove any remnants that were left in the base of the wound" and there was no harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2019-00045 |
| MDR Report Key | 8535852 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-22 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-04-22 |
| 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 LTD |
| Manufacturer Street | FIRST AVENUE DEESIDE INDUSTRIAL PARK |
| Manufacturer City | DEESIDE, FLINTSHIRE CH5 2NU |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CH5 2NU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUACEL/AQUACEL AG - EXUDATE MANAGEMENT HYDROFIBER DRESSING ROPE |
| Generic Name | DRESSING,WOUND,HYDROPHILIC |
| Product Code | NAC |
| Date Received | 2019-04-22 |
| Model Number | 403770 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LTD |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH5 2NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-22 |