MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-21 for HALYARD 42216NS manufactured by La Ada De Acuna, S. De. R. L. De C. V..
[145650837]
Avid medical is the manufacturer of a custom procedure tray ref: (b)(4), cataract pack that includes the following component: cover, back table 44 x 78, ref: (b)(4) manufactured by la ada de acuna, s. De. R. L. De c. V. (registration: (b)(4)). Avid medical received a complaint on (b)(6) 2019 originated by (b)(4), or (b)(4), (b)(6) alleging that the back table cover was leaving loose fibers on the sterile field and consequently in patient's eyes. The cover, back table 44 x 78 part was available for evaluation. Avid medical issued formal complaint # (b)(4) to the manufacturer per ref: (b)(4), manufacturer lot: ac9029081. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1047429-2019-00010 |
| MDR Report Key | 8627595 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-04-26 |
| Date Added to Maude | 2019-05-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICHOLE EARLY |
| Manufacturer Street | 9000 WESTMONT DR STONEHOUSE COMMERCE PARK |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal | 23168 |
| Manufacturer Phone | 8283387568 |
| Manufacturer G1 | AVID MEDICAL, INC. |
| Manufacturer Street | 9000 WESTMONT DRIVE STONEHOUSE COMMERCE PARK |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 23168 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALYARD |
| Generic Name | DRAPE |
| Product Code | PUI |
| Date Received | 2019-05-21 |
| Model Number | 42216NS |
| Lot Number | AC9029081 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LA ADA DE ACUNA, S. DE. R. L. DE C. V. |
| Manufacturer Address | AV. HIDALGO NO. 6 ESQ. BLVD. LUIS DONALDO COLOSIO COL.EDUCATIVA, NOGALES SONORA 84093 MX 84093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-21 |