MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for VERSASTEP PLUS VS101015P manufactured by Covidien.
[184874911]
Seal came off in patient's abdomen - seal was removed from patient. Manufacturer response for 15mm verastep, versastep (per site reporter). No response from manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9877812 |
| MDR Report Key | 9877812 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-07-25 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-03-25 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | VERSASTEP PLUS |
| Generic Name | LAPAROSCOPE, GENERAL PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2019-07-26 |
| Model Number | VS101015P |
| Catalog Number | VS101015P |
| Lot Number | J9B1738Y |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |