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.
[74054346]
(b)(4). The device history review for the product dermahook 1/2 hook 10 pkg/bx 6 hks/pkg, lot #73b1600483. Investigation did not show issues related to the complaint. The device has not been returned for investigation at this time. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[74054347]
The elastic broke during use on 3 different hooks. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[78991706]
(b)(4). The customer returned one unit of 382805 dermahook 1/2 hook pkg/bx 6 hks/pkg for investigation. The sample was returned with its original packaging but opened. The returned sample was visually inspected with and without magnification. Upon visual examination, it was found that five of the thermoplastic elastometric (tpe) bands were broken. One of the bands was broken at a spot that isn't right on the edge of the card that holds the bands, but the other four broken bands were broken at the edge of the card. Further examination revealed that the bands did not appear to thin at the point of separation and had no discoloration. This suggests that the bands did not break due to over exposure to heat and/or uv lighting. Since the package was received opened, it could not be determine when the bands were broken. (b)(4). A corrective action is not required at this time as it could not be determined what caused the complaint issue. Since the sample was received open, it could not be determined when the bands were broken. The reported complaint of "broken" was confirmed based upon visual examination of the returned other remarks: sample. The sample was received open in its original packaging. There were 5 broken tpe bands. One of the bands was broken at a spot that isn't right on the edge of the card that holds the bands, but the other four broken bands were broken at the edge of the card. Further examination revealed that the bands did not appear to thin at the point of separation and had no discoloration. This suggests that the bands did not break due to over exposure to heat and/or uv lighting. A device history record review was performed with no evidence to suggest a manufacturing related cause. Since the sample was received open , it could not be determined when the bands were broken. No further action will be taken.
Patient Sequence No: 1, Text Type: N, H10
[78991707]
The elastic broke during use on 3 different hooks. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00408 |
| MDR Report Key | 6533707 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-01 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-03-28 |
| Date Mfgr Received | 2017-05-19 |
| 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 | 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 | 73B1600483 |
| Device Expiration Date | 2017-08-29 |
| 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 | 2017-05-01 |