MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-09-28 for NON-ABSORBABLE SURGICAL SUTURES 8065307901 manufactured by Alcon Precision Device - Sinking Spring.
[4794029]
A nurse reported two or three pts had a post-operative infection following a procedure. The reason for the infection is unk at this time. The pt's info is unk at this time. This is one of two reports being filed for this facility. This report represents the suture. Additional info has been requested but none has been received to date.
Patient Sequence No: 1, Text Type: D, B5
[12235845]
Investigation, including root cause analysis, is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable info becomes available. Additional info has been requested but none has been received to date. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2014-00157 |
| MDR Report Key | 4135699 |
| Report Source | 01,05 |
| Date Received | 2014-09-28 |
| Date of Report | 2014-09-01 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-09-01 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2014-10-03 |
| 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 | JANET MORAN |
| Manufacturer Street | 6201 SOUTH FREEWAY, R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152742 |
| Manufacturer G1 | ALCON PRECISION DEVICE - SINKING SPRING |
| Manufacturer Street | 714 COLUMBIA AVE. |
| Manufacturer City | SINKING SPRING PA 19608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NON-ABSORBABLE SURGICAL SUTURES |
| Generic Name | NON-ABSORBABLE SUTURE |
| Product Code | GAS |
| Date Received | 2014-09-28 |
| Model Number | 8065307901 |
| Catalog Number | 8065307901 |
| Lot Number | 908342M |
| ID Number | NA |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON PRECISION DEVICE - SINKING SPRING |
| Manufacturer Address | 714 COLUMBIA AVE. SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-28 |