MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-11-17 for CVS PHARMACY UPC#050428266540 894117 manufactured by Shandong Sincere Medical Products Co., Ltd..
[92373108]
As of 11/14/2017 aso reviewed records for physical properties performed on pre-shipment samples of the same lot number with results acceptable in addition to evaluate the biocompatibility studies and latex screening. Complaint database was reviewed; there was no negative trend identified for the associated product. Trending is completed on all products monthly.
Patient Sequence No: 1, Text Type: N, H10
[92373109]
Consumer stated that product caused her blisters and rash around the area where she had a biopsy. Consumer asked if the product contains latex.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2017-00044 |
| MDR Report Key | 7042559 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-11-17 |
| Date of Report | 2017-10-27 |
| Date of Event | 2017-10-27 |
| Report Date | 2017-10-30 |
| Date Reported to Mfgr | 2017-10-30 |
| Date Mfgr Received | 2017-10-27 |
| Device Manufacturer Date | 2013-02-05 |
| Date Added to Maude | 2017-11-17 |
| 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 | MR. FEDERICO JULIAO |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal | 34240 |
| Manufacturer G1 | ASO LLC |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34240 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CVS PHARMACY |
| Generic Name | ELASTIC STRETCH NET |
| Product Code | FQM |
| Date Received | 2017-11-17 |
| Model Number | UPC#050428266540 |
| Catalog Number | 894117 |
| Lot Number | 3099-100812 |
| Device Expiration Date | 2018-02-04 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHANDONG SINCERE MEDICAL PRODUCTS CO., LTD. |
| Manufacturer Address | 168 WEIXU ROAD, JINGZHI TOWN, ANQUI, SHANDONG PROVINCE 262100 CH 262100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-17 |