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 2019-05-15 for DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG 382805 manufactured by Teleflex Medical.
[145632587]
Qn#: (b)(4). The facility has communicated that the device is not available for investigation. A verification of failure mode reported in the current manufacturing process was conducted as follows: 125 samples were taken from the current production p/n dermahook 1/2 hook 10 pkg/bx 6 hks/pkg, lot# 73e1900056, the samples were functionally inspected, and issue reported as rubber bands breaking was not observed in the current manufacturing process. The device history reviews the product dermahook 1/2 hook 10 pkg/bx 6 hks/pkg lot# 73k1800935 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 to confirm the alleged defect. At this time since the sample is not available it is not possible to determine the source of the defect reported. The customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and to 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
[145632588]
It was reported that the elastic is breaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2019-00600 |
| MDR Report Key | 8612388 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-03-19 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2018-10-31 |
| Date Added to Maude | 2019-05-15 |
| 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 | 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-POWE |
| Product Code | HAO |
| Date Received | 2019-05-15 |
| Catalog Number | 382805 |
| Lot Number | 73K1800935 |
| 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 | 2019-05-15 |