MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2015-07-30 for DERMAHOOK 1/4 HOOKS 382805 manufactured by Teleflex Medical.
[6037904]
Alleged event: the dermahooks are dry rotting which is evident through the packaging. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[14309777]
Qn#(b)(4). The device history review for the dermahook 1/2 hook 10 pkg/bx 6 hks/pkg lot number 73k1400269 did not show issues related to the complaint. The device sample has not been returned to the manufacturer for investigation at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[25416552]
(b)(4). One (1) pouch from p/n 382805 dermahook 1/2 hook (b)(4) was received not used, closed in original packaging, lot # 73k1400269 was confirmed. During visual inspection it was observed that the rubber bands were deteriorated. Failure mode dry rot reported by the customer was confirmed during visual inspection. Samples received confirm the defect reported by the customer "dry rot. " a review was conducted of the ifu and it was found that the customer is directed to "inspect each durahook and dermahook prior to use, specifically to ensure the integrity of the elastic band. If the elastic band contains tears, splits or other damage, do not use. " in addition, this defect was found before to use in the patient. Therefore a corrective action is not required at this time. However we will continue to monitor trending of similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[25416553]
Alleged event: the dermahooks are dry rotting which is evident through the packaging. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2015-00543 |
| MDR Report Key | 4952548 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-07-30 |
| Date of Report | 2015-07-22 |
| Date of Event | 2015-07-17 |
| Date Mfgr Received | 2015-09-07 |
| Device Manufacturer Date | 2014-10-13 |
| Date Added to Maude | 2015-07-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 1/4 HOOKS |
| Product Code | GDG |
| Date Received | 2015-07-30 |
| Returned To Mfg | 2015-07-24 |
| Catalog Number | 382805 |
| Lot Number | 73K1400269 |
| Device Expiration Date | 2016-02-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-30 |