MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-10 for DCP 3MM UNILATERAL PROCEDURE KIT DCP315-UNI manufactured by Quest Medical, Inc..
[1534406]
On 06/17/08, (b)(4) received a phone call from (b)(4). (b)(4) stated that dr (b)(6) was performing a dcp procedure. He inserted the catheter, inflated the catheter and noticed that the balloon would not hold pressure. He removed the device and opened another kit to complete the procedure without any pt complications. The facility is requesting to be reimbursed for the cost of the kit. The device was saved and they are waiting to return it to us for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[8694226]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2010-00016 |
| MDR Report Key | 1802445 |
| Report Source | 05,06 |
| Date Received | 2010-08-10 |
| Date of Report | 2010-08-10 |
| Date of Event | 2009-03-02 |
| Report Date | 2008-07-01 |
| Date Reported to FDA | 2008-07-01 |
| Date Mfgr Received | 2008-06-17 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2010-08-23 |
| 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 | KATHRYN JAYNE |
| Manufacturer Street | ONE ALLENTOWN PKWY. |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723909800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DCP 3MM UNILATERAL PROCEDURE KIT |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT |
| Product Code | HNW |
| Date Received | 2010-08-10 |
| Returned To Mfg | 2008-07-02 |
| Catalog Number | DCP315-UNI |
| Lot Number | 32044 |
| Device Expiration Date | 2010-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-10 |