MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-08-21 for UNKNOWN TICRON UNKNOWN-TICRON manufactured by Covidien.
[4866689]
Procedure type: orthopedic. According to the reporter: the surgeon, (b)(6), reported that he was using a size 5 ti-cron suture and was passing it through the greater trochanter during the repair of the gluteal tendon when the needle snapped off inside the patient's bone. The surgeon stated that he would have had to destroy the greater trochanter in order to retrieve the broken needle, so he made the decision to leave it in situ. Follow up on (b)(6) 2014: (b)(6) confirmed that the patient has been informed of the incident.
Patient Sequence No: 1, Text Type: D, B5
[11990844]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[21665420]
Additional information has been received that the device in question is not a covidien product. (b)(4). Date of initial report sent: 08/22/2014.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2014-00292 |
| MDR Report Key | 4044782 |
| Report Source | 05,06 |
| Date Received | 2014-08-21 |
| Date of Report | 2014-08-06 |
| Date Mfgr Received | 2014-08-06 |
| Date Added to Maude | 2014-08-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| 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 | UNKNOWN TICRON |
| Generic Name | TI CRON |
| Product Code | GAO |
| Date Received | 2014-08-21 |
| Catalog Number | UNKNOWN-TICRON |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO SANTO DOMINGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-21 |