MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for OLSEN HEGAR 6.5" INSERT 510445 manufactured by Teleflex Medical.
[41684006]
(b)(4). The device has not been returned for investigation at this time. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[41684007]
Alleged event: a part of the needle holder broke off and fell into the dog. The piece was retrieved and there was no harm to the patient. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[43338350]
(b)(4). Device history record (dhr) was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns. No concerns were noted with reference to 510445 sample of 510445 was received for evaluation. The blade is broken at the pivot point. Rust and dried blood were observed inside the fracture plane. Due to the repeat incidents with this customer - it is likely that this is a site specific issue related to method of use. There are no other complaints for this issue. Sample of 510445 was received for evaluation. The blade is broken at the pivot point. Rust and dried blood were observed inside the fracture plane. Previous complaints were submitted by the same customer.
Patient Sequence No: 1, Text Type: N, H10
[43338351]
Alleged event: a part of the needle holder broke off and fell into the dog. The piece was retrieved and there was no harm to the patient. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2016-00052 |
| MDR Report Key | 5531835 |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-02-19 |
| Date Mfgr Received | 2016-04-08 |
| Date Added to Maude | 2016-03-29 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLSEN HEGAR 6.5" INSERT |
| Generic Name | HOLDER,NEEDLE;ORTHOPEDIC |
| Product Code | HXK |
| Date Received | 2016-03-29 |
| Returned To Mfg | 2016-03-22 |
| Catalog Number | 510445 |
| Lot Number | H2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-29 |