MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-12 for PURSTRING* INSTRUMENT 215 020240 manufactured by Covidien.
[65036273]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[65036274]
Customer states: purse-string suture failed due to malalignment of the jaws.
Patient Sequence No: 1, Text Type: D, B5
[68158081]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2017-00081 |
| MDR Report Key | 6245270 |
| Date Received | 2017-01-12 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-12-07 |
| Date Mfgr Received | 2017-01-27 |
| Date Added to Maude | 2017-01-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926373 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURSTRING* INSTRUMENT 215 |
| Generic Name | STAPLE, IMPLANTABLE |
| Product Code | GDJ |
| Date Received | 2017-01-12 |
| Returned To Mfg | 2017-01-27 |
| Model Number | 020240 |
| Catalog Number | 020240 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 SANTO DOMINGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-12 |