MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-21 for PATIENT RETURN PAD 6050P1 manufactured by Coopersurgical, Inc..
[50961351]
Coopersurgical inc. Is currently investigating the reported complaint condition. The actual device involved in the complaint will be returned for evaluation. Once the investigation is completed a follow-up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[50961352]
"customer reports the unit did not warn that the patient pad was not properly attached , during rep demo /test patient pad was still attached to the adhesive on top of the unit when the physician tested the unit it delivered an electrical charge to the pad which should not have happened. Physician would like to send back the remaining... " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[55342098]
(b)(4). Investigation : initiated manufacturer's investigation, no sample returned, x-review dhr, x-inspect returned samples, inspect stock product. Analysis and findings: the individual pad is purchased from and pouched by a supplier. Coopersurgical packages (b)(4) pads/pouches into a sales box configuration. A review of the dhr's (176310, 176311, 176312, 176313) did not show any abnormalities. A review of two year complaint history shows one other similar complaint for this issue. The investigation found the customer uses a bovie aaron 1250 electrosurgical generator which is not a coopersurgical generator. The reported pad in this complaint was not returned and thus, could not be analyzed. Nine returned unopened pads were removed from the pouch, visually inspected and found to be acceptable. It is unclear what may have caused the issue as the returned pads appeared to be correct. Corrective actions/correction and/or corrective action : none at this time. Will continue to monitor for trending. Corrective action level 3 train personnel, x-none, reason: n/a. Was the complaint confirmed? No review and closure capa required? X-recommended continuous improvement program (cip) complaint closure letter required? Ncmr issued? #: other regulatory action needed: preventative action activity reviewed. Monitor and trend to cip.
Patient Sequence No: 1, Text Type: N, H10
[55342099]
"customer reports the unit did not warn that the patient pad was not properly attached , during rep demo /test patient pad was still attached to the adhesive on top of the unit when the physician tested the unit it delivered an electrical charge to the pad which should not have happened. Physician would like to send back the remaining... " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2016-00049 |
| MDR Report Key | 5811753 |
| Date Received | 2016-07-21 |
| Date of Report | 2016-06-24 |
| Date of Event | 2016-06-22 |
| Date Mfgr Received | 2016-06-22 |
| Device Manufacturer Date | 2015-11-23 |
| Date Added to Maude | 2016-07-21 |
| 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 | 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 | PATIENT RETURN PAD |
| Generic Name | PATIENT RETURN PAD |
| Product Code | ODR |
| Date Received | 2016-07-21 |
| Model Number | 6050P1 |
| Catalog Number | 6050P1 |
| Lot Number | 201510294 |
| Device Expiration Date | 2017-10-28 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2016-07-21 |