MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-21 for MEDLINE manufactured by Medline.
[81045103]
The abdominal drape for chs c-section lot # 17nb2154 came in with a blue tape securing each corner of her bag window of the abdominal drape. In two separate cases, the tape dislodged from the drape traveling into the abdominal i cavity as per (b)(6). Reason for use: drape for c sections.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071215 |
| MDR Report Key | 6740075 |
| Date Received | 2017-07-21 |
| Date of Report | 2017-06-20 |
| Date of Event | 2017-06-19 |
| Date Added to Maude | 2017-07-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MEDLINE |
| Generic Name | CHS C-SECTION CESAREAN SECTION TRAY PLUS II |
| Product Code | OHM |
| Date Received | 2017-07-21 |
| Lot Number | 17NB2154 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-21 |