MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-22 for ESMARK 23578-163 manufactured by Avcor Healthcare Products Inc..
[34096202]
Patient Sequence No: 1, Text Type: N, H10
[34096203]
I opened an esmark band onto the sterile field and it had a long black hair wrapped around it. Manufacturer response for x-mark - latex-free esmark bandage 6''w x 3 yds l, x-mark (per site reporter): they gave me their email address and told me to email them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5317886 |
| MDR Report Key | 5317886 |
| Date Received | 2015-12-22 |
| Date of Report | 2015-12-15 |
| Date of Event | 2015-12-14 |
| Report Date | 2015-12-15 |
| Date Reported to FDA | 2015-12-15 |
| Date Reported to Mfgr | 2015-12-15 |
| Date Added to Maude | 2015-12-22 |
| 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 | 3 |
| 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 | ESMARK |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2015-12-22 |
| Model Number | 23578-163 |
| Lot Number | 101214 |
| ID Number | 820120-90 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVCOR HEALTHCARE PRODUCTS INC. |
| Manufacturer Address | 2750 113TH ST. STE. 300 GRAND PRAIRIE TX 75050 US 75050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-22 |