MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-20 for OP-1 IMPLANT 10025 manufactured by Olympus Biotech.
[3130041]
On (b)(6) 2013, olympus biotech pvg received a report of an adverse event in a female pt (initial cd, dob (b)(6)1942) who received one unit of op-1 implant on (b)(6) 2013, as part of a procedure to treat a clavicular nonunion. Approx three days postoperatively the pt reported to her physician that she was experiencing redness and swelling at the surgical site and surrounding area. Five days postoperatively the pt was seen by the surgeon, who reported 'redness, swelling, tightness and skin irritation' at the surgery site and surrounding area, with 'more swelling than what he would have expected'. Additional info has been requested from the surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1224732-2013-00001 |
| MDR Report Key | 2977915 |
| Report Source | 05 |
| Date Received | 2013-02-20 |
| Date of Report | 2013-01-28 |
| Date of Event | 2013-01-19 |
| Date Mfgr Received | 2013-01-28 |
| Date Added to Maude | 2013-02-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 35 SOUTH ST. |
| Manufacturer City | HOPKINTON MA 01748 |
| Manufacturer Country | US |
| Manufacturer Postal | 01748 |
| Manufacturer Phone | 5084165200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OP-1 IMPLANT |
| Generic Name | NONE |
| Product Code | MPW |
| Date Received | 2013-02-20 |
| Catalog Number | 10025 |
| Lot Number | FC1212001 |
| Device Expiration Date | 2013-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS BIOTECH |
| Manufacturer Address | HOPKINTON MA 01748 US 01748 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-20 |