MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for VASCULAR PACK DYNJ49366 manufactured by Medline Industries.
[144701467]
The adhesive covering on the base of the suture boot holder of the medline vascular pack was unable to be fully removed, therefore unable to be secured to the back table drapes. This product was discarded and replaced with a similar product with no issues. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086510 |
| MDR Report Key | 8597110 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-05-06 |
| Date Added to Maude | 2019-05-09 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | VASCULAR PACK |
| Generic Name | CARDIOVASCULAR PROCEDURE KIT |
| Product Code | OEZ |
| Date Received | 2019-05-09 |
| Model Number | DYNJ49366 |
| Catalog Number | DYNJ49366 |
| Lot Number | 19ABY118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |