MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for COVIDIEN STAPLER SKIN 35 MM WIDE ROTATING PRW35 4100 manufactured by Covidien.
[184851071]
Pt had colon surgery on (b)(6) 2019. On (b)(6) 2019, pt developed a fever of 103. 1. Abd was cultured and grew yeast. The pt was taken back to the operating room on (b)(6). Op findings include further dissection into the pelvis; however, revealed some fibrillar purulent exudate around the drain and much denser adhesions. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093871 |
| MDR Report Key | 9865204 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-11-14 |
| Date Added to Maude | 2020-03-23 |
| 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 | 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 | COVIDIEN STAPLER SKIN 35 MM WIDE ROTATING |
| Generic Name | STAPLER, SURGICAL |
| Product Code | GAG |
| Date Received | 2020-03-20 |
| Model Number | PRW35 |
| Catalog Number | 4100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-20 |