MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-03-30 for DURAPLUG EXTENDED WEAR PLUGS 0077 manufactured by Surgical Specialties Corp., (dba Angiotech).
[2578317]
The date of event is estimated. The distributor reported that a doctor had a patient present with mucopurulent secretion in the punctum three (3) months post insertion of a 2. 0mm x 3. 0mm pcl punctum plug. The patient was treated with antibiotics and an anti-inflammatory drug with slow clinical improvement. With pressure washing the lachrymal with antibiotics and applications of a topical antibiotic, the patient healed well without additional surgery. A temporary device (0. 3mm x 1. 5mm gellansert) was inserted prior to inserting the pcl plug. The patient had no pre-existing medical conditions or allergies that would have affected the healing process or contributed to the reaction. The surgeon stated that this was the second patient he had seen within a few days with this similar type of reaction following implantation of a pcl device from the same manufacturing lot.
Patient Sequence No: 1, Text Type: D, B5
[9896308]
The actual used device was not removed or returned for review. Sterile samples from this finished good lot were not available for testing. Method: no samples were returned for review. Therefore no evaluation was performed. Results, conclusions: no samples were returned for review. Therefore no evaluation was performed. Relevant portions of the device history record was reviewed and no corresponding issues were identified during the manufacturing processes or at final inspection. The sterility records confirmed that all product from this finished good lot/load was sterile when released. There were no other events reported for this particular finished good lot and no similar events were reported for the pcl extended wear plugs. The gellanserts are not flushed from the canal prior to inserting the extended wear devices. Therefore, the root cause for the reported post-operative reaction can not be determined at this time. (b)(4), item # 0077, duraplug pcl extended wear plugs. Lot m446690.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2522801-2012-00004 |
| MDR Report Key | 2519760 |
| Report Source | 05,08 |
| Date Received | 2012-03-30 |
| Date of Report | 2012-03-30 |
| Date of Event | 2011-07-01 |
| Date Mfgr Received | 2012-03-12 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2012-08-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEFFREY LEWIS, SR. MAANGER |
| Manufacturer Street | 100 DENNIS DR. |
| Manufacturer City | READING PA 19606 |
| Manufacturer Country | US |
| Manufacturer Postal | 19606 |
| Manufacturer Phone | 6104041000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURAPLUG EXTENDED WEAR PLUGS |
| Generic Name | PCL PLUG |
| Product Code | LZU |
| Date Received | 2012-03-30 |
| Model Number | 0077 |
| Catalog Number | 0077 |
| Lot Number | M446690 |
| ID Number | NA |
| Device Expiration Date | 2015-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES CORP., (DBA ANGIOTECH) |
| Manufacturer Address | READING PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-30 |