MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-17 for CO-FLEX manufactured by Andover Healthcare Inc..
[47596641]
Patient Sequence No: 1, Text Type: N, H10
[47596642]
Young female, status post (s/p) liver transplant had a bandage placed on finger and it was not removed until 48 hours later; the finger appears necrotic with possibility of losing tip of finger. Patient had finger stick for blood work, ace bandage applied secondary to inability to stop bleeding, admitted, and bandage removed 48 hours later on the unit. Necrotic area noted upon ace bandage removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5731900 |
| MDR Report Key | 5731900 |
| Date Received | 2016-06-17 |
| Date of Report | 2016-06-13 |
| Date of Event | 2016-05-08 |
| Report Date | 2016-06-13 |
| Date Reported to FDA | 2016-06-13 |
| Date Reported to Mfgr | 2016-06-13 |
| Date Added to Maude | 2016-06-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CO-FLEX |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2016-06-17 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANDOVER HEALTHCARE INC. |
| Manufacturer Address | 9 FANARAS DR. SALISBURY MA 01952 US 01952 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-17 |