MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-29 for UNNA FLEX ELASTIC UNNA BOOT 650941 manufactured by Convatec Limited.
[52066059]
Based on the available information, this event is deemed to be a reportable malfunction. No additional patient/ event details have been 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
[52066060]
It was reported the bandage leaks which contributed to stains on the primary package. "the package was closed upon receipt but probably had a hole. " the product was not used on a patient.
Patient Sequence No: 1, Text Type: D, B5
[58041530]
Additional information that was obtained confirmed the following: a return sample is not available for return. The primary complaint is that the packaging is leaking. It cannot be confirmed that the primary package stain is as a result of the reported leakage or that there was a hole seen in the primary packaging. Additionally, the bandage is packaged as a moist/wet bandage, not a dry bandage. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. Reported to the fda on october 11, 2016.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000317571-2016-00063 |
| MDR Report Key | 5832951 |
| Date Received | 2016-07-29 |
| Date of Report | 2016-07-13 |
| Date of Event | 2016-07-13 |
| Date Mfgr Received | 2017-06-15 |
| Device Manufacturer Date | 2014-09-18 |
| Date Added to Maude | 2016-07-29 |
| 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 | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNNA FLEX ELASTIC UNNA BOOT |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2016-07-29 |
| Model Number | 650941 |
| Lot Number | 1600030262 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH52NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-29 |