MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for ADSON DISSECT HK BLT 7.75" SURGICAL UNKNOWN manufactured by Teleflex Medical.
[137055052]
(b)(4). The device investigation is pending. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[137055053]
It was reported that the item listed is the closest based on the customer description as no model number is given and said it is at least 6 years old. During a surgical procedure on the spine the tip of nerve retractor fell off into the cavity. There was no injury to the patient and the tip was extracted with no issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2019-00055 |
| MDR Report Key | 8358430 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-01-30 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-02-21 |
| 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 | 0 |
| Brand Name | ADSON DISSECT HK BLT 7.75" |
| Generic Name | HOOK, SURGICAL, GENERAL & PLAS |
| Product Code | HNL |
| Date Received | 2019-02-21 |
| Returned To Mfg | 2019-02-13 |
| Catalog Number | SURGICAL UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-21 |