MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-07-31 for DERMAHOOK 1/2 HOOK 382805 manufactured by Teleflex Medical.
[6253921]
Alleged event: the elastics are shredding and they are very thin. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[13712712]
Qn#(b)(4). The device history review for the product dermahook 1/2 hook 10 pkg/bx 6 hks/pkg, lot number 73c1500433 did not show issues related to the complaint. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2015-00548 |
| MDR Report Key | 4956821 |
| Report Source | 05,06,07 |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-22 |
| Date of Event | 2015-07-21 |
| Date Mfgr Received | 2015-07-22 |
| Device Manufacturer Date | 2015-03-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 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 |
| Product Code | GDG |
| Date Received | 2015-07-31 |
| Catalog Number | 382805 |
| Lot Number | 73C1500433 |
| Device Expiration Date | 2016-09-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-07-31 |