MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-11 for JOBST COMPRESSION STOCKINGS manufactured by Bsn Medical.
[45229226]
Compression stocking with side zipper. Per decedent's sister: j. G. Had great difficulty zipping up compression socks. Sister found j. G. Deceased in his bedroom "blood everywhere - he bled out when the zipper pinched the artery as he was forcefully (assumed) pulling on the zipper". Per decedent's sister, forceful pulling on the zipper was common. J. G. Had thin skin and was on coumadin therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062226 |
| MDR Report Key | 5652253 |
| Date Received | 2016-05-11 |
| Date of Report | 2016-05-09 |
| Date of Event | 2016-03-21 |
| Date Added to Maude | 2016-05-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| 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 | 0 |
| Brand Name | JOBST COMPRESSION STOCKINGS |
| Generic Name | COMPRESSION STOCKINGS |
| Product Code | DWL |
| Date Received | 2016-05-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BSN MEDICAL |
| Manufacturer Address | 5825 CARNEGIE BLVD CHARLOTTE NC 28209 US 28209 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-05-11 |