MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-28 for THIN PREP PAP 500 TSTS/CS 02500 manufactured by Coopersurgical, Inc..
[44667731]
Coopersurgical inc. Is currently investigating the reported complaint condition. The device involved in the complaint has not been returned by the customer for evaluation. Once the investigation is completed a follow-up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44667732]
"end user complains that bag of spatulas has some sharp plastic around collection type that the edges that are sharp and cutting patients and causing bleeding. There are a least a few spatulas in all bags according to customer. The end user would not like replacements. They just want the spatulas to all be the same without sharp edges. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[55159929]
Coopersurgical inc. Is currently investigating the reported complaint condition. The device involved in the complaint has not been returned by the customer for evaluation. Once the investigation is completed a follow-up report will be filed. Reference e-complaint: (b)(4). Folow up investigation x-initiated manufacturer's investigation x-no sample returned x-review dhr inspect returned samples x-inspect stock product analysis and findings an evaluation of the complainant samples could not be conducted since they will not be returned. The plastic spatulas, part number 11080b, are molded at coopersurgical. The spatulas are placed into a bag with brushes and the ifu. The 20 bags are placed into a box which is shipped to the customer. A review of the dhr did not find any abnormalities. A sampling of spatulas stock inventory were taken and in some cases, flash was found at the distal end of the part. This was traced back to lot numbers 171854 and 171855 only. Non-conforming material report (ncmr) 2653 was issued to document the non-conformity. Correction and/or corrective action all stock inventory of lot numbers 171854 and 171855 were scrapped. Changed the nozzle tips in each cavity to better control the amount of material in the mold. Quality alert qa-00012 was issued and placed at the molding station and the packing station. Appropriate personnel were trained to the quality alert. Corrective action level 2 x-train personnel was the complaint confirmed? Yes review and closure x-recommended continuous improvement program (cip) capa required? Complaint closure letter required? Ncmr issued? Other regulatory action needed: *preventative action activity reviewed. Trend and monitor to cip.
Patient Sequence No: 1, Text Type: N, H10
[55159930]
"end user complains that bag of spatulas has some sharp plastic around collection type that the edges that are sharp and cutting patients and causing bleeding. There are a least a few spatulas in all bags according to customer. The end user would not like replacements. They just want the spatulas to all be the same without sharp edges. " reference e-complaint number : (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2016-00007 |
| MDR Report Key | 5614229 |
| Date Received | 2016-04-28 |
| Date of Report | 2016-07-05 |
| Date of Event | 2016-02-03 |
| Date Mfgr Received | 2016-02-03 |
| Device Manufacturer Date | 2015-07-17 |
| Date Added to Maude | 2016-04-28 |
| 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 | MR. NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THIN PREP PAP 500 TSTS/CS |
| Generic Name | THIN PREP PAP 500 TSTS/CS |
| Product Code | OHL |
| Date Received | 2016-04-28 |
| Model Number | 02500 |
| Catalog Number | 02500 |
| Lot Number | 168875 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-28 |