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.
[74103592]
(b)(4). The device history review for the product dermahook 1/2 hook 10 pkg/bx 6 hks/pkg, lot #73b160048383 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
[74103593]
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
[75631513]
(b)(4),. The customer returned three representative samples of product 382805 dermahook 1/2 hook 10 pkg/bx 6 hks/pkg for investigation. All three of the samples were returned unopened. The returned samples were visually inspected with and without magnification. Upon visual examination, it was found that the one package had 1 broken thermoplastic elastometric (tpe) band, one package had 2 broken tpe bands, and the other package had 0 broken tpe bands. Further examination revealed that tpe bands in all three packages showed signs of discoloration, including at the locations where the bands broke. The discoloration of the bands is a sign that the bands had over exposure to heat and/or uv lighting. Reference files (b)(4) for investigation photos. A corrective action is not required at this time as it appears that operational context caused or contributed to this event. The reported complaint of "broken" was confirmed based upon visual examination of the returned samples. Three representative samples were returned in place of the actual samples. There were 3 broken bands among the three returned samples. All of the other remarks: samples had tpe bands that had discoloration. The discoloration of the bands indicates that the bands were overly exposed to heat and/or uv lighting. A device history record review was performed with no evidence to suggest a manufacturing related cause. Therefore, based upon the damage observed, operational context caused or contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[75631514]
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 | 3003898360-2017-00407 |
| MDR Report Key | 6534770 |
| 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 | 2017-05-19 |
| 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 | 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 |