MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-02-16 for UNKNOWN manufactured by Unknown, Unk.
[67549691]
Date of event not provided by the complainant. Product name unknown; product unspecified. Product common name unknown; product unspecified - product code pag / pai. Lot number not provided by the complainant. Product expire date unknown; lot number not provided. Product catalog number unknown, product unspecified. Surgeon name not provided by the complainant. Implant date not provided by the complainant. Concomitant products - unspecified neomedic device and unspecified ams device; implant date(s) not provided by the complainant. G5: 510(k) unknown; product unspecified. As requested by the fda, we have made note of the product code in section g8. The product code listed is not necessarily the product code assigned to the device 510(k), but rather the product code that seems the most appropriate based on the surgical procedure in which the product was implanted. Product manufacture date unknown; lot number unknown. Based on the information provided by the complainant, details regarding a specific correlation between a cook biotech incorporated manufactured product? S performance and the alleged injury remain unknown. A root cause of the claim allegations is inconclusive due to the lack of details provided by the complainant. All other matters relating to this litigation are being handled by our attorney. A follow-up mdr will be filed if additional details are obtained. Date of event not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[67549692]
The patient was reportedly implanted with an unspecified neomedic device and an unspecified ams device for treatment of stress urinary incontinence and pelvic organ prolapse. Specifics regarding date of implant, surgeon? S name, and name of the facility where the implant occurred were not provided by the complainant. The patient reportedly underwent an extensive revision on (b)(6) 2013 to locate and remove mesh that was holding her bladder in the wrong position and causing extreme pain which remains ongoing. The patient and her attorney have alleged that as a result of these products being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment. Cook was named as a defendant in the litigation; however, the complainant did not specify that a cook device was implanted in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2017-00001 |
| MDR Report Key | 6335187 |
| Report Source | CONSUMER |
| Date Received | 2017-02-16 |
| Date of Report | 2017-02-15 |
| Date Mfgr Received | 2017-02-08 |
| Date Added to Maude | 2017-02-16 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PERRY GUINN |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Product Code | PAG |
| Date Received | 2017-02-16 |
| Catalog Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN, UNK |
| Manufacturer Address | UNKNOWN UNKNOWN UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-02-16 |