MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-01 for DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG 382805 manufactured by Teleflex Medical.
[74047590]
(b)(4). The device history review for product dermahook 1/2 hooks 10 pkg/bx 6 hks/pkg, lot #73b1600483 investigation did not show issues related to the complaint. Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect. At this time due the sample is not available is not possible to determine the source of the defect reported. The customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determine the root cause. If the alleged defect samples become available at a later date, this complaint will be updated accordingly. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[74047591]
The elastic broke off during normal use. The patient's condition was reported as unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00406 |
| MDR Report Key | 6533609 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-01 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-04-04 |
| Device Manufacturer Date | 2016-02-17 |
| Date Added to Maude | 2017-05-01 |
| 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 | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| 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 |
| Generic Name | INSTRUMENT,SURGICAL,NON-POWERED |
| Product Code | HAO |
| Date Received | 2017-05-01 |
| Catalog Number | 382805 |
| Lot Number | 73B1600483 |
| Device Expiration Date | 2017-08-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-05-01 |