MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-09 for POLYSORB 0 ES-9 173016 manufactured by Covidien.
[3303988]
During cuff repair needle broke off and lodged deeply in pt. It required 2. 5 additional hrs with fluoroscopy to locate and retrieve the broken needle tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028585 |
| MDR Report Key | 2916393 |
| Date Received | 2013-01-09 |
| Date of Report | 2013-01-09 |
| Date of Event | 2013-01-03 |
| Date Added to Maude | 2013-01-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYSORB 0 ES-9 |
| Generic Name | SUTURE |
| Product Code | KOG |
| Date Received | 2013-01-09 |
| Model Number | 173016 |
| Lot Number | 8240181X |
| Device Expiration Date | 2017-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Brand Name | COVIDIEN ENDOSTITCH |
| Generic Name | ENDOSTITCH |
| Product Code | MFJ |
| Date Received | 2013-01-09 |
| Model Number | 170052 |
| Lot Number | N2K02504 #173016 |
| Device Expiration Date | 2017-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-01-09 |