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.
[74101437]
(b)(4). The device history review for the product dermahook 1/2 hook 10 pkg/bx 6 hks/pkg, lot #73k1600692 investigation did not show issues related to the complaint. The investigation report has not been submitted at this time. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[74101438]
The elastic broke during use on 3 different hooks. The patient's condition was reported as unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
[76649829]
(b)(4). The customer returned one unit of 382805 dermahook 1/2 hook pkg/bx 6 hks/pkg for investigation. Only one hook and suture thread was returned. No tpe bands were returned. The sample was returned without its original packaging. The returned sample was visually inspected with and without magnification. Visual examination revealed that the sample appears used as there is biological material present on the device. The hook and suture that was returned appears to be intact. Since the tpe band was not returned, it could not be determined how it broke off from the hook and suture. Reference files (b)(4) for investigation photos. Since the tpe band was not returned, it could not be confirmed that it broke. Therefore, no corrective action is required at this time. The reported complaint of "broken" could not be confirmed since the tpe band was not returned. Only the hook and suture were returned and both appeared to be completely intact. A device history record review was performed with no evidence to suggest a manufacturing related cause. Since the tpe band was not returned, it could not be confirmed that it broke. No further action will be taken.
Patient Sequence No: 1, Text Type: N, H10
[76649830]
The elastic broke during use on 3 different hooks. The patient's condition was reported as unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00404 |
| MDR Report Key | 6534635 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-01 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-03-30 |
| Date Mfgr Received | 2017-05-19 |
| Device Manufacturer Date | 2016-10-25 |
| 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 | 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 |
| Generic Name | INSTRUMENT,SURGICAL,NON-POWERED |
| Product Code | HAO |
| Date Received | 2017-05-01 |
| Returned To Mfg | 2017-04-19 |
| Catalog Number | 382805 |
| Lot Number | 73K1600692 |
| Device Expiration Date | 2018-04-03 |
| 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 | 2017-05-01 |