MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2016-08-01 for UNNA-FLEX? ELASTIC UNNA BOOT 650941 manufactured by Convatec Limited.
[50915441]
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. Reported to the fda on august 01, 2016. (b)(4)..
Patient Sequence No: 1, Text Type: N, H10
[50915442]
It was reported the primary package was shipped in good condition, however it was received broken at the client. Pictures were provided that appear to have an open weld on the carton.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2016-00064 |
| MDR Report Key | 5837841 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2016-08-01 |
| Date of Report | 2016-07-15 |
| Date of Event | 2016-07-15 |
| Date Mfgr Received | 2016-07-15 |
| Device Manufacturer Date | 2015-11-24 |
| Date Added to Maude | 2016-08-01 |
| 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 | 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 | 2016-08-01 |
| Model Number | 650941 |
| Lot Number | 1600030297 |
| Operator | LAY USER/PATIENT |
| 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 | 2016-08-01 |