MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-20 for SADDLELOOP 1541 manufactured by Quest Medical, Inc..
[44038813]
The hospital reported issues encountered while using the saddleloop device. They reported that the buckle was coming apart and the elastic portion of the device was breaking. The complaint report indicated this was a recuring issue but they kept this one device to send to the manufacturer for evaluation. There were no patient complications reported as a result of the alleged problem. The device lot number was not provided to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
[44800460]
The complaint condition was confirmed. It was determined there was insufficient adhesive used or inadequate time allowed for adhesive curing on this device. The dhr could not be reviewed because the lot number was unknown. 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
| Report Number | 1649914-2016-00014 |
| MDR Report Key | 5591318 |
| Date Received | 2016-04-20 |
| Date of Report | 2016-04-28 |
| Date of Event | 2016-03-15 |
| Date Mfgr Received | 2016-03-15 |
| Date Added to Maude | 2016-04-20 |
| 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 | SADDLELOOP |
| Generic Name | MANUAL SURGICAL INSTRUMENT |
| Product Code | GAE |
| Date Received | 2016-04-20 |
| Returned To Mfg | 2016-03-18 |
| Model Number | 1541 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-04-20 |