MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-14 for DURAHOOK 1/4 HOOK 382800 manufactured by Teleflex Medical.
[24245282]
(b)(4). The device history review for the product durahook 1/4 hook 10 pkg/bx 6 hks/pkg, lot number 73m1400048 investigation did not show issues related to the complaint. The device sample has been returned to the manufacturer but the investigation report has not been submitted at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[24245283]
Alleged event: the durahooks are dry rotting which is evident through the packaging. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[25416131]
(b)(4). One (1) pouch from p/n 382800 durahook 1/4 hook (b)(4) was received not used, closed in original packaging, lot # 73m1400048 was confirmed with received sample, during visual inspection was observed; components looked well assembled, rubber bands did not appear to have damage. Functional inspection: pouch was opened to review the rubber bands conditions (undamaged), then rubber bands were fastened to a paperboard, after rubber bands were stretched at full capacity, no quality issues were found during functional testing (rubber bands were not broken. Sample received did not confirm the defect reported by the customer dry rot. A functional inspection was performed and the device worked properly; not broken. Therefore, a corrective action is not required at this time. However, we will continue to monitor trending of similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[25416132]
Alleged event: the durahooks are dry rotting which is evident through the packaging. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2015-00530 |
| MDR Report Key | 5005323 |
| Date Received | 2015-08-14 |
| Date of Report | 2015-07-17 |
| Date of Event | 2015-07-17 |
| Date Mfgr Received | 2015-09-03 |
| Device Manufacturer Date | 2014-12-03 |
| Date Added to Maude | 2015-08-14 |
| 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 | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURAHOOK 1/4 HOOK |
| Product Code | GDG |
| Date Received | 2015-08-14 |
| Returned To Mfg | 2015-07-24 |
| Catalog Number | 382800 |
| Lot Number | 73M1400048 |
| Device Expiration Date | 2016-04-12 |
| 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 | 2015-08-14 |