STAPLE, IMPLANTABLE Adverse Event — Malfunction (MDR 2647580-2020-01444)
STAPLE, IMPLANTABLE Adverse Event — Malfunction (MDR 2647580-2020-01444) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: STAPLE, IMPLANTABLE; Generic name: STAPLE, IMPLANTABLE; Manufacturer: US SURGICAL PUERTO RICO.
| Device | STAPLE, IMPLANTABLE |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | US SURGICAL PUERTO RICO |
| Report number | 2647580-2020-01444 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | Consumer |
| Narrative | ADDITIONAL INFO RECEIVED: A4, B7 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION |
| Source | openFDA MAUDE (device adverse events) |
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