MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-07-24 for BIO-OSS COLLAGEN BLOCK 100 MG UNK manufactured by Geistlich Pharma Ag.
[21751211]
Report by patient. (b)(6) 2004: implantation of bio-oss collagen for root resection. Pain and discharge from tooth after surgery. (b)(6) 2004: tooth extraction. Wound healing problems during 4 months afterwards. On (b)(6) 2005: removal of bio-oss collagen, normal healing after surgery. Since (b)(6) 2006: restart of pain in treated region. Damage of trigeminus nerve during surgery (exact time point or surgery not specified). Severe pain, treatment by special consultant for pain treatment since (b)(6) 2005 (medication: gabapentin, baclofen, amitryptiline). The patient provided medical records. The are written by hand and could therefore not deciphered completely. However, deviations from the patient's report could be identified (i. E. (b)(6) 2005: normal wound healing, whereas the patient described wound healing problems during that period).
Patient Sequence No: 1, Text Type: D, B5
[21925825]
This event could be related to the patient's allergy to animal product as bio-os collagen contains porcine collagen. The labeling warns of the possibility of allergic reactions. As this appears to be labeled event, while serious, no further follow up is deemed necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614442-2006-00001 |
| MDR Report Key | 2326197 |
| Report Source | 04 |
| Date Received | 2007-07-24 |
| Date of Report | 2006-03-24 |
| Date of Event | 2005-12-01 |
| Date Mfgr Received | 2006-03-24 |
| Device Manufacturer Date | 2003-10-31 |
| Date Added to Maude | 2011-11-08 |
| 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 Contact | BETTINA SCHMID |
| Manufacturer Street | BAHNHOFSTRASSE 40 |
| Manufacturer City | WOLHUSEN 6110 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6110 |
| Manufacturer Phone | 14925678 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-OSS COLLAGEN |
| Generic Name | DENTAL BONE VOID FILLER |
| Product Code | NPM |
| Date Received | 2007-07-24 |
| Model Number | BLOCK 100 MG |
| Catalog Number | UNK |
| Lot Number | 030623 |
| ID Number | NA |
| Device Expiration Date | 2007-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEISTLICH PHARMA AG |
| Manufacturer Address | WOLHUSEN 6110 SZ 6110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2007-07-24 |