MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for INPATIENT PORT DRESSING WITH BIOPATCH DT21865A manufactured by Centurion Medical Products Corp.
[178349404]
Inpatient port dressing was opened and port dressing was stuck to the sterile drape inside wrap. When it was pulled loose the adhesive sticker had a piece of the sterile drape paper attached. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092827 |
| MDR Report Key | 9681752 |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-31 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | INPATIENT PORT DRESSING WITH BIOPATCH |
| Generic Name | WOUND DRESSING KIT |
| Product Code | MCY |
| Date Received | 2020-02-06 |
| Catalog Number | DT21865A |
| Lot Number | 2019072390 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS CORP |
| Manufacturer Address | WILLIAMSTON MI 48895 US 48895 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |