MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-15 for DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG 382805 manufactured by Teleflex Medical.
[26173715]
(b)(4). The device history review for the product dermahook 1/2 hook (b)(4), lot number 73e1500506 investigation did not show issues related to the complaint. The device sample has not been returned for investigation at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[26173716]
Alleged event: the rubber bands are snapping. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[37862571]
(b)(4). Visual inspection: (b)(4) - all samples passed visual inspection with zero defects. Functional evaluation: (b)(4)- force to stretch (200% and 300%) all samples passed. Results are statistically equivalent to results achieved during design verification testing. Elongation at break tests - all samples passed. (b)(4) - force to stretch tests (200% and 300%). All samples passed. After completion of testing, we conclude that the product is performing as expected and meets all design requirements.
Patient Sequence No: 1, Text Type: N, H10
[37862572]
Alleged event: the rubber bands are snapping. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2015-00644 |
| MDR Report Key | 5079195 |
| Date Received | 2015-09-15 |
| Date of Report | 2015-09-08 |
| Date of Event | 2015-09-04 |
| Date Mfgr Received | 2015-09-10 |
| Device Manufacturer Date | 2015-05-27 |
| Date Added to Maude | 2015-09-15 |
| 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 | DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG |
| Product Code | GDG |
| Date Received | 2015-09-15 |
| Returned To Mfg | 2015-09-14 |
| Catalog Number | 382805 |
| Lot Number | 73E1500506 |
| Device Expiration Date | 2016-11-05 |
| 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 | 2015-09-15 |