MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-04 for LACRICATH LACRIMAL DUCT BALLOON CATHETER LDC508T manufactured by Quest Medical, Inc..
[52391707]
Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
[52391708]
The hospital reported an issue encountered with the 5mm lacricath device during use. The report stated that the catheter was inserted into the patient when the alleged issue occurred. They reported that they inflated the device but the air leaked right back out. The report stated as a result they removed the catheter and used another one (from a new kit) to successfully complete the procedure. There were no patient complications reported as a result of the alleged event. The catheter was discarded and not returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5
[56570671]
The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition. There were no more devices of the same lot remaining in inventory for device investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2016-00038 |
| MDR Report Key | 5846735 |
| Date Received | 2016-08-04 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-07-06 |
| Date Mfgr Received | 2016-07-06 |
| Device Manufacturer Date | 2015-10-02 |
| Date Added to Maude | 2016-08-04 |
| 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 | MRS. AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LACRICATH LACRIMAL DUCT BALLOON CATHETER |
| Generic Name | LACRIMAL INTUBATION SETS |
| Product Code | OKS |
| Date Received | 2016-08-04 |
| Model Number | LDC508T |
| Lot Number | 0498975C01 |
| Device Expiration Date | 2018-10-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-04 |