MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-03 for FISHERBRAND? LATEX-FREE COHESIVE FLEXIBLE BANDAGES N/A 22363114 manufactured by Suzhou Medsport Products Co., Ltd.
[74357788]
The customer reported a complaint pertaining to the fisher catalog number 22363114, fisherbrand? Latex-free cohesive flexible bandages. The customer reported that the product was wrapped around the patient's arm after the patient went for a lab draw. At some point after the bandage was wrapped around the patient's arm, the product rolled up and restricted blood flow to the patient's arm. It was communicated the potential exists that the bandage could not be directly seen because it was covered by the patient's gown. The patient developed hemorrhage and had the diagnosis of compartment syndrome in the right forearm intramuscular hematoma. The customer reported that the patient was taking a blood thinning medication, and the patient had to go to surgery for a fasciotomy, followed by another surgery for a secondary closure. The customer stated that the standard of care for patients on anticoagulant is to apply pressure and not to wrap a patient's arm with a bandage. In this case, the customer did not follow the established standard of care for this patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517925-2017-00001 |
| MDR Report Key | 6541716 |
| Date Received | 2017-05-03 |
| Date of Report | 2017-05-03 |
| Date Facility Aware | 2017-04-04 |
| Report Date | 2017-05-03 |
| Date Reported to FDA | 2017-05-03 |
| Date Reported to Mfgr | 2017-05-03 |
| Date Added to Maude | 2017-05-03 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | FISHERBRAND? LATEX-FREE COHESIVE FLEXIBLE BANDAGES |
| Generic Name | ELASTIC BANDAGE |
| Product Code | FQM |
| Date Received | 2017-05-03 |
| Model Number | N/A |
| Catalog Number | 22363114 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUZHOU MEDSPORT PRODUCTS CO., LTD |
| Manufacturer Address | NO. 128 FANGZHOU ROAD SUZHOU INDUSTRIAL PARK, SUZHOU, CHINA 215123 CH 215123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-03 |