MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-08-09 for DRAPE OPHTHALMIC INCISE W/POUCH D1061 manufactured by Quiroproductos De Cuauhtemoc S. De R.l. De C.v..
[82400143]
Cardinal health is proactively filing this complaint. The device history record (dhr) was reviewed and no quality issues were reported. An evaluation of the returned representative sample was completed for material, folds, pouch and finished dimensions. No defects were found. Based on the evaluation of the sample and the dhr, the issue of aggressive adhesive was not confirmed. In addition, all finished goods are made from qualified materials that are tested before use. Final finished product must meet product specification and process requirements before final release to salable inventory. A root cause was not determined and no corrective action was taken. We will continue to monitor for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
[82400144]
Received complaint that stated the adhesive on the drape was too strong, and peeled the skin and ripped eye lashes off when removing. The complaint was originally received in may, and multiple attempts were made to obtain information from the customer, however the end user did not respond. On (b)(6) the customer reported that the end user had contacted them with information that antibiotic ointment and steroids were used for peeled skin; and that skin and lashes are ok now. The customer reported that they doubted there would be any further specific information from the end user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2017-00120 |
| MDR Report Key | 6778502 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-08-09 |
| Date of Report | 2017-08-09 |
| Date of Event | 2017-05-04 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2015-04-23 |
| Date Added to Maude | 2017-08-09 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer G1 | QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V. |
| Manufacturer Street | AV. RIO CHUVISCAR Y CARRETERA |
| Manufacturer City | CUAUHTEMOC, CHIHUAHUA 31543 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31543 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAPE OPHTHALMIC INCISE W/POUCH |
| Generic Name | DRAPE, PATIENT, OPHTHALMIC |
| Product Code | HMT |
| Date Received | 2017-08-09 |
| Returned To Mfg | 2017-06-06 |
| Catalog Number | D1061 |
| Lot Number | 15DBC127 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V. |
| Manufacturer Address | AV. RIO CHUVISCAR Y CARRETERA CUAUHTEMOC, CHIHUAHUA 31543 MX 31543 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-09 |